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This is an example showing example shows a sample report table, trial design, and results data of Study #123 dataset for study 123 for the determination of the in vitro genotoxicity potential of 10 tobacco products in using the in vitro Micronucleus Assay

Info
red font - indicates potential for CT code lists green font - links to other domains purple font - to be discussed

...

title	Study 123, Report (for reference only, will be deleted?)

micronucleus assay.

Expand

title	Sample Report Table for Study 123

Image Added

Dataset wrap

Rowcaps

Rows 1-2:	Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this example study.
Row 3:	Shows that this study was conducted as a GLP study.
Rows 4-5:	Show the study start date and study title.
Rows 6-7:	Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study.
Row 8:	Shows the applicant's organization.
Row 9:	Shows that the applicant's study reference ID is not applicable.
Rows 10-13:	Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The study director is associated with the test facility.
Rows 14-16:	Show that TSGRPID (TSGRPID=2) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).
Row 17:	Shows the study type for this study.
Row 18:	Shows that this study includes a Mammalian Cell Micronucleus Assay.
Rows 19-20:	Show that the species is human and the cell line is TK6 lymphoblastoid in this study.

Dataset2

Row	STUDYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM

For the purposes of team review of the example data, the report is included in this section:

Sample data #1: Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay

Study info: This study was performed to assess the in vitro genotoxicity of 10 different tobacco products containing 1% to 2% nicotine. The genotoxic potential was determined using the in vitro micronucleus test with TK6 lymphoblastoid suspension cells. The study was conducted in compliance with the following documents:

OECD TG 487 (2010): Guideline for the testing of chemicals: In vitro mammalian cell micronucleus test.
BL SOP 132: Determination of the in vitro genotoxicity of condensates from tobacco products and ingredients for tobacco products / electronic vapour products – in vitro micronucleus test (IVM) with TK6 cells.

The cells were exposed to increasing dose levels of tobacco product using short term treatment in the presence and absence of an external metabolic activation system (ST+/-S9 mix) as well as a long term treatment in the absence of an external metabolic activation system (LT-S9 mix).

Toxicity was calculated as relative increase in cell count (RICC), relative cell count (RCC) and relative population doubling (RPD). RPD is the cytotoxicity measure used for the assessment. RICC and RCC are also reported but not considered for the assessment.

Note: OECD GUIDELINE FOR THE TESTING OF CHEMICALS

Population Doubling = [log (Post-treatment cell number ÷ Initial cell number)] ÷ log 2

Conclusion: All tobacco product evaluated did not induce any signs of severe toxicity or genotoxicity in any of the treatments and do not fulfil the criteria to be classified as genotoxic.

Reported results: (only listed the result of one tobacco product as an example)

...

Adjusted p-values calculated for the micronucleus frequencies for every dose level as compared to the corresponding solvent control after ST in the presence and absence of S9 mix as well as LT in the absence of S9 mix. One way ANOVA with posthoc Dunnett’s test for multiple comparisons for the dose response and a two tailed unpaired student’s t-test for the comparison of positive and negative control were used. The difference between the samples is considered statistically significant at p≤0.05.

Treatment

Test date

Concentration [µg/ml]

...

Fold increase of MN

over background

Adjusted p- value

...

Significant increase Y/N

ST+ S9

25.05.2022

...

1250

...

0.9

...

0.9973

...

N

...

2500

...

0.9

...

0.9517

...

N

...

3750

...

0.6

...

0.2654

...

N

...

5000

...

0.9

...

0.9895

...

N

...

CPA [5µg/ml]

...

3.1

...

0.0003

...

Y

ST-S9

25.05.2022

...

1250

...

1.6

...

0.6408

...

N

...

2500

...

1.3

...

0.8995

...

N

...

3750

...

2.9

...

0.0106

...

N

...

5000

...

1.0

...

> 0.9999

...

N

...

Bleo [0.2µg/ml]

...

3.8

...

0.0002

...

Y

LT-S9

25.05.2022

...

1250

...

0.7

...

0.5958

...

N

...

2500

...

1.3

...

0.6378

...

N

...

3750

...

0.5

...

0.1146

...

N

...

5000

...

1.1

...

0.9929

...

N

...

Bleo [0.5µg/ml]

...

2.9

...

0.0047

...

Y

Bleo: Bleomycin; CPA: Cyclophosphamid A; statistically significant increases are highlighted in bold.

Expand

title	Study 123, Raw data (for reference only, will be deleted?)

Image Removed

TSPARM

Expand

title	ts.xpt (trial summary, study level parameters)

Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
Assumption: A Trial (study) can have more than one assay type
Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study
This example currently shows SPDEVID and DUREFID in BOTH the TS domain and the TX domain, but we should discuss if this should only ever be in TX (with the same value for all sets if there is only one device used)
Assumption: SPDEVID (sponsor defined device identifier) should be added at the trial set level (tx.xpt) - we can discuss if this should be in TS when there is only one device for a study
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

	TSVAL	TSVALNF
1	123

MNvit

TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123

MNvit

	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123

	TS	1		GLPFL	GLP Flag	Y
4	123

MNvit

TS

1

STSTDTC

Study Start Date

2022-05-25

4


5	123

MNvit

TS

1

STITLE

Study Title

Determination of the in vitro genotoxicity potential

of 10 tobacco products in the in vitro Micronucleus Assay

using the in vitro Neutral Red Uptake assay
6	123

5123MNvit

TS

1

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0

6


7	123

MNvit

TS

1

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30

7


8	123

MNvit

TS

1

SSPONSOR

APPLCNT

Sponsor Organization

Applicant

Example

Sponsor

Applicant, Inc.

8


9	123

MNvit

TS

1

SPREFID

APREFID

Sponsor's

Study Reference ID

NOT APPLICABLE

9

10

123

MNvit

TS

1

TSTFNAM

Test Facility Name

Example

Tox

Test Lab Name

10


11	123

MNvit

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

11


12	123

MNvit

TS

1

TFCNTRY

Test Facility Country

USA

12


13	123

MNvit

TS

1

STDIR

Study Director

Dr. R. Smith

13


14	123

MNvit

TS

1

2

GLPFLGLP FlagY14123

TSTGDNAM	Testing Guideline Name	GUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15	123

MNvit

TS

1

2

ASTDAssay Standard

TSTGDORG

Testing Guideline Organization

OECD

Test No. 487

15


16	123

MNvit

TS

1

ASTDV

2

TSTGDVER

Testing Guideline

Assay Standard

Version

2016

29-

07

July-

29

2016

16


17	123

MNvit

TS

1

SSTYP

Study Type

GENOTOXICITY IN VITRO

17123MNvitTS1SSSTYPStudy Sub TypeIn Vitro Micronucleus


18	123	TS	1	GNTXAID	Genetic Toxicology Assay Identifier	MNvit
19	123	TS	1	SPECIES	Species

Homo Sapiens

HUMAN

19


20	123

MNvit

TS

1

??Test System?TK6 Lymphoblastoid Suspension Cells20123MNvitTS1SPDEVIDSponsor defined device identifierPUFFMASTER3K21123MNvitTS1DUREFIDSmoke RegimenMedium Intensity Regimen Expand

title	tx.xpt (trial sets)

CELLLN

Cell Line

TK6 LYMPHOBLASTOID

This example Trial Sets dataset shows information about the test conditions for set A1 and A2 in this example study. Sets A1 and A2 can be seen in the first and second rows respectively of the sample report Table 1 (above). For brevity, the TX dataset and the findings (GT) dataset do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets.

SET (what sponsor calls it)

Dataset wrap

Name	tx

Rowcaps

Rows 1-23:

Show trial set parameters and values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short-term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0".

Set A1 is associated with the first row in the sample report table for study 123.

Rows 24-46:

Show trial set parameters and values that comprise the test conditions for trial set A2. Set A2 is the data for the short-term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250".

Set A2 is associated with the second row in the sample report table for study 123.

Dataset2

Row	STUDYID	DOMAIN	SETCD	SET

During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level

A1: Image Removed

A2: Image Removed

Row

STUDYID

ASSAYID

DOMAIN

SETCD

	TXSEQ	TXPARMCD	TXPARM	TXVAL

123(table 1, row

MNvitTX

A1

1

, ST exposure with S9)ST+S9METACTMetabolic Activation (this is the type of activation used)+S9

123

MNvit

TX

A1

ST+S9

METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)123

_C0	1	MTACTIND	Metabolic Activating Agent Name	+S9
2	123

MNvit

TX

A1

ST+S9

TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)

_C0	2	METACTFL	Presence of Metabolic Activation Flag	Y
3	123

MNvit

TX

A1

ST+S9_C0

TRTDRTOL

3

IVTDMIN

In vitro Treatment Duration

Tolerance

Minimum	3
4	123

MNvit

TX

A1

ST+S9_C0

4

TRTDURU

IVTDTRG

Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)H

In vitro Treatment Duration Target	3.5
5	123

123MNvit

TX

A1

ST+S9_C0

5

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

Tobacco ProdA123

IVTDMAX	In vitro Treatment Duration Maximum	4
6	123

MNvit

TX

A1

ST+S9_C0

ITVTYPE

type of intervention article

choices of values: product; negative control; positive control

Product

6	IVTDU	In vitro Treatment Duration Unit	HOURS
7	123

123MNvit

TX

A1

ST+S9

ITVCONCConcentration of intervention article

_C0	7	RCVDMIN	Recovery Duration Minimum	23.5
8

0

123

MNvit

TX

A1

ST+S9

ITVCONCUConcentration Unit

_C0	8	RCVDTRG	Recovery Duration Target	24
9

ug/ml

123

MNvitTS

TX

A1

ST+S9

SPDEVIDSponsor defined device identifier

_C0	9	RCVDMAX	Recovery Duration Maximum	24.5
10

PUFFMASTER3KTS

123

MNvit

TX

A1

ST+S9

DUREFIDSmoke RegimenMedium Intensity Regimen

_C0	10	RCVDU	Recovery Duration Unit	HOURS
11	123

MNvit

TX

A2

(table 1, row 2)

METACTMetabolic Activation (should there be two parms? Presence, type)?+S9123MNvitTXA2TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)3123MNvitTXA2TRTDRTOLTreatment Duration Tolerance123MNvitTXA2TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)H123MNvitTXA2INTRVNname of the intervention articleTobacco ProdA123MNvitTXA2ITVTYPEtype of intervention articleProduct123MNvitTXA2ITVCONCConcentration of i a 1250123MNvitTXA2ITVCONCUConcentration Unitug/ml123MNvitTSA2SPDEVIDSponsor defined device identifierPUFFMASTER2023123MNvitTSA2DUREFIDSmoke RegimenHigh Intensity Regimen... Expand

title	du.xpt (a findings domain for device in-use properties)

We use DU for smoking regimen. Note that a separate DI dataset will be needed to show identifying parameters of the "PUFFMASTER3K" smoking machine, but is currently not shown for brevity.

Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).

Smoking regimen is represented in --REFID (we made up a value of "Medium Intensity Regimen"; we can update with something realistic)
The smoking regimen is carried out by the smoking machine/device shown in SPDEVID, Sponsor defined device identifier, "PUFFMASTER3K"
Do we need both SPDEVID AND DUREFID?

du.xpt

Row

STUDYID

DOMAIN

SPDEVID

DUSEQ

DUREFID

DUGRPID

DUTESTCD

DUTEST

DUORRES

DUORRESU

DUSTRESC

DUSTRESN

DUSTRESU

1123DUPUFFMASTER3K1Medium Intensity RegimenPUFFPROFPuff ProfileSQUARESQUARE2123DUPUFFMASTER3K2Medium Intensity Regimen

PUFFDUR

Puff Duration

1.25

sec

1.25

sec

3123DUPUFFMASTER3K3Medium Intensity Regimen

PUFFINT

Puff Interval

3

PUFF/min

3

PUFF/min

4123DUPUFFMASTER3K4Medium Intensity Regimen

PUFFBLCK

Puff Block

25

%

25

%

5123DUPUFFMASTER3K5Medium Intensity RegimenNUMPUFFTotal Number of Puffs

200

PUFF

200

PUFF

6123DUPUFFMASTER3K6Medium Intensity RegimenPUFFVOLPuff Volume

10

mL

10

mL

7123DUPUFFMASTER3K7Medium Intensity RegimenPUFFRNGPuff Range

100-200

8123DUPUFFMASTER3K8Medium Intensity Regimen1PUFFPAUSPuff Pause

60

s

60

s

9123DUPUFFMASTER3K9Medium Intensity Regimen1PUFFPINTPuff Pause Interval

10

PUFF

10

PUFF

10123DUPUFFMASTER20231

Canadian Intense Regime

PUFFPROFPuff ProfileSQUARESQUARE11123DUPUFFMASTER20232Canadian Intense Regime

PUFFDUR

Puff Duration

2.00

sec

2.00

sec

12123DUPUFFMASTER20233Canadian Intense Regime

PUFFINT

Puff Interval

4

PUFF/min

4

PUFF/min

13123DUPUFFMASTER20234

Canadian Intense Regime

PUFFBLCK

Puff Block

0

%

0

%

14123DUPUFFMASTER20235Canadian Intense RegimeNUMPUFFTotal Number of Puffs

200

PUFF

200

PUFF

15123DUPUFFMASTER20236Canadian Intense RegimePUFFVOLPuff Volume

10

mL

10

mL

16123DUPUFFMASTER20237

Canadian Intense Regime

PUFFRNGPuff Range

100-200

17123DUPUFFMASTER20238Canadian Intense Regime1PUFFPAUSPuff Pause

60

s

60

s

18123DUPUFFMASTER20239Canadian Intense Regime1PUFFPINTPuff Pause Interval

10

PUFF

10

PUFF

A1	ST+S9_C0	11	INCBTMP	Incubation Temperature	37
12	123	TX	A1	ST+S9_C0	12	INCBTMPU	Incubation Temperature Unit	C
13	123	TX	A1	ST+S9_C0	13	ATMRHP	Atmospheric Relative Humidity Percent	50
14	123	TX	A1	ST+S9_C0	14	ATMCO2P	Atmospheric CO2 Percent	5
15	123	TX	A1	ST+S9_C0	15	SPTOBID	Applicant-defined tobacco identifier	CIG01a
16	123	TX	A1	ST+S9_C0	16	EXPTYP	Exposure Type	Submerged
17	123	TX	A1	ST+S9_C0	17	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	TX	A1	ST+S9_CO	18	ITVNAM	Intervention Article Name	Tobacco ProdA
19	123	TX	A1	ST+S9_C0	19	ITVTYPE	Intervention Article Type	Negative Control
20	123	TX	A1	ST+S9_C0	20	ITVCONC	Intervention Article Concentration	0
21	123	TX	A1	ST+S9_C0	21	ITVCONCU	Intervention Article Concentration Unit	ug/ml
22	123	TX	A1	ST+S9_C0	22	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
23	123	TX	A1	ST+S9_C0	23	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
24	123	TX	A2	ST+S9_C1250	24	MTACTIND	Metabolic Activating Agent Name	+S9
25	123	TX	A2	ST+S9_C1250	25	METACTFL	Presence of Metabolic Activation Flag	Y
26	123	TX	A2	ST+S9_C1250	26	IVTDMIN	In vitro Treatment Duration Minimum	3
27	123	TX	A2	ST+S9_C1250	27	IVTDTRG	In vitro Treatment Duration Target	3.5
28	123	TX	A2	ST+S9_C1250	28	IVTDMAX	In vitro Treatment Duration Maximum	4
29	123	TX	A2	ST+S9_C1250	29	IVTDU	In vitro Treatment Duration Unit	HOURS
30	123	TX	A2	ST+S9_C1250	30	RCVDMIN	Recovery Duration Minimum	23.5
31	123	TX	A2	ST+S9_C1250	31	RCVDTRG	Recovery Duration Target	24
32	123	TX	A2	ST+S9_C1250	32	RCVDMAX	Recovery Duration Maximum	24.5
33	123	TX	A2	ST+S9_C1250	33	RCVDU	Recovery Duration Unit	HOURS
34	123	TX	A2	ST+S9_C1250	34	INCBTMP	Incubation Temperature	37
35	123	TX	A2	ST+S9_C1250	35	INCBTMPU	Incubation Temperature Unit	C
36	123	TX	A2	ST+S9_C1250	36	ATMRHP	Atmospheric Relative Humidity Percent	50
37	123	TX	A2	ST+S9_C1250	37	ATMCO2P	Atmospheric CO2 Percent	5
38	123	TX	A2	ST+S9_C1250	38	SPTOBID	Applicant-defined tobacco identifier	CIG01a
39	123	TX	A2	ST+S9_C1250	39	EXPTYP	Exposure Type	Submerged
40	123	TX	A2	ST+S9_C1250	40	SAMTYP	Sample Type	Total Particulate Matter in DMSO
41	123	TX	A2	ST+S9_C1250	41	ITVNAM	Intervention Article Name	Tobacco ProdA
42	123	TX	A2	ST+S9_C1250	42	ITVTYPE	Intervention Article Type	Product
43	123	TX	A2	ST+S9_C1250	43	ITVCONC	Intervention Article Concentration	1250
44	123	TX	A2	ST+S9_C1250	44	ITVCONCU	Intervention Article Concentration Unit	ug/ml
45	123	TX	A2	ST+S9_C1250	45	SPDEVID	Applicant-defined Device Identifier	PUFFMASTER2023
46	123	TX	A2	ST+S9_C1250	46	SMKRGM	Smoking Regimen	HIGH INTENSITY REGIMEN

Dataset wrap

Name	relref

Rowcaps

Row 1:	Shows the value of REFID=C0. This REFID refers to the trial set with a SETCD of "A1", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.
Rows 2-5:	Show the values of 4 observational units (C0_Count1 through C0_Count4) that are within the parent experimental unit, REFID=C0. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.
Row 6:	Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of "A2", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.
Rows 7-10:	Show the values of 4 observational units (C1250_Count1 through C1250_Count4) that are within the parent experimental unit, REFID=C1250. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.

Dataset2

tableid	relref

Row	STUDYID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123	A1	C0		1	EXPERIMENTAL UNIT/TRIAL SET
2	123	A1	C0-Count1	C0	2	OBSERVATIONAL UNIT
3	123	A1	C0-Count2	C0	2	OBSERVATIONAL UNIT
4	123	A1	C0-Count3	C0	2	OBSERVATIONAL UNIT
5	123	A1	C0-Count4	C0	2	OBSERVATIONAL UNIT
6	123	A2	C1250		1	EXPERIMENTAL UNIT/TRIAL SET
7	123	A2	C1250-Count1	C1250	2	OBSERVATIONAL UNIT
8	123	A2	C1250-Count2	C1250	2	OBSERVATIONAL UNIT
9	123	A2	C1250-Count3	C1250	2	OBSERVATIONAL UNIT
10	123	A2	C1250-Count4	C1250	2	OBSERVATIONAL UNIT

di.xpt (copied v1.0 of medical devices IG)

This example is a copy of Example 1 from di.xpt in SDTMIG-MD v1.0 but with values for SPDEVID and DIVAL revised slightly.
Should I remove the FDA UDI (row 5) unless CTP has or plans to establish UDI values?

Example 1
This shows records for two devices where the sponsor felt that the type, manufacturer, model number, and serial number were necessary for unique identification. In addition, there was a post-marketing UDI identifier available for the first device.

Rows 1-5 show the records for a device given a SPDEVID of ABC001
Rows 5-8 show the records for a device given a SPDEVID of ABC999

Dataset wrap

Name	gt

Rowcaps

Rows 1-3, 8:	Show percentage result values that apply to GTREFID=C0. REFID=C0, as shown in the RELREF dataset, relates this data to the trial set in the first row of table 1 in the sample report table for study 123.
Rows 4-7:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C0-Count1 through C0-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.
Rows 9-11, 16:	Show percentage result values that apply to GTREFID=C1250. REFID=C1250, as shown in the RELREF dataset, relates this data to the trial set in the second row of table 1 in the sample report table for study 123.
Rows 12-15:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C1250-Count1 through C1250-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.

Expand

title	di.xpt (a study reference domain for unique device identification)

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	2011-001	DI	PUFFMASTER3K	1	DEVTYPETYPE	Device Type	MRIAll values in DIVAL corresponding to DEVTYPE in all examples need to be updated to conform with FDA Product Classification codes
2	2011-001	DI	PUFFMASTER3K	2	MANUF	Manufacturer	Acme Machines
3	2011-001	DI	PUFFMASTER3K	3	MODEL	Model Number	45-JFI
4	2011-001	DI	PUFFMASTER3K	4	SERIAL	Serial Number	456789132-AXQ
5	2011-001	DI	PUFFMASTER3K	5	FDAUDI	FDA Unique Device Identifier	456789123xyz
6	2015-001	DI	PUFFMASTER2023	1	DEVTYPETYPE	Device Type	MRI
7	2015-001	DI	PUFFMASTER2023	2	MANUF	Manufacturer	Acme Machines
8	2015-001	DI	PUFFMASTER2023	3	MODEL	Model Number	62-PLC
9	2015-001	DI	PUFFMASTER2023	4	SERIAL	Serial Number	215964564-NFS

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Old Version 63

New Version Current

Key

SET (what sponsor calls it)