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The following example illustrates the representation of an ENDS tobacco product's identifiers and descriptors using the TO domain. Note that this example makes use of TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the two distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOSCATTOVALTOVALU
1TOB09TOVAPE-Z27

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIERENDS
2TOB09TOVAPE-Z272TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERClosed E-Cigarette
3TOB09TOVAPE-Z273MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Vapes USA
4TOB09TOVAPE-Z274TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIEREveryday Rich Tobacco
5TOB09TOVAPE-Z275PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORBOX
6TOB09TOVAPE-Z276PRDQUANProduct QuantityNEW PRODUCTPRODUCT DESCRIPTOR1E-CIGARETTE
7TOB09TOVAPE-Z277LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR107.2mm
8TOB09TOVAPE-Z278DIAMETERDiameterNEW PRODUCTPRODUCT DESCRIPTOR9mm
9TOB09TOVAPE-Z279NICTNCNCNicotine ConcentrationNEW PRODUCTPRODUCT DESCRIPTOR2mg/L
10TOB09TOVAPE-Z2710PRPYLGLYPropylene GlycolNEW PRODUCTPRODUCT DESCRIPTOR50%
11TOB09TOVAPE-Z2711VEGGLYVegetable GlycerinNEW PRODUCTPRODUCT DESCRIPTOR50%
12TOB09TOVAPE-Z2712CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTORTOBACCO
13TOB09TOVAPE-Z2713VOLUMEEVolume, E-liquidNEW PRODUCTPRODUCT DESCRIPTOR1mL
14TOB09TOVAPE-Z2714WATTWattageNEW PRODUCTPRODUCT DESCRIPTOR5.2Watt
15TOB09TOVAPE-Z2715BATTCAPCBattery CapacityNEW PRODUCTPRODUCT DESCRIPTOR600mAh
16TOB09TOVAPE-Z2716DISPCRTGDisposable CartridgeNEW PRODUCTPRODUCT DESCRIPTORY
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The manufacturing parameter specifications of the ENDS product as intended for used are represented in the Product Design Parameters (PD) domain. The example below shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally. 

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pd.xpt

RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1TOB09PDVAPE-Z27

1

DRWRSTDraw Resistance90.080.0120.0mm H2O
2TOB09PDVAPE-Z272PUFCNTPuff Count300290310
3TOB09PDVAPE-Z273CRTVOLCartridge Volume315mL
4TOB09PDVAPE-Z274HTELNUMNumber of Heating Elements11

1


5TOB09PDVAPE-Z275HTELGTHHeating Element Length32.73.3mm
6TOB09PDVAPE-Z276HTEDIAMHeating Element Diameter32.93.2mm
7TOB09PDVAPE-Z277HTELRSTHeating Element Resistance0.750.251.5ohm
8TOB09PDVAPE-Z278HTELRNGHeating Element Range175100250C
9TOB09PDVAPE-Z279HTELCFGHeating Element ConfigurationSPIRALSPIRALSPIRAL
10TOB09PDVAPE-Z2710BTVLTORG

Battery Voltage Operating Range

4.536V
11TOB09PDVAPE-Z2711BTCRTORG

Battery Current Operating Range

10006501600mAh
12TOB09PDVAPE-Z2712BATCAPCBattery Capacity11008003000mAh
13TOB09PDVAPE-Z2713BATNOMV

Battery Nominal Voltage

4.24.04.5V
14TOB09PDVAPE-Z2714BTCRTRTBattery Current Rating250020002800mA
15TOB09PDVAPE-Z2715BTCHTPLBattery Charging Temperature Limits200100315C
16TOB09PDVAPE-Z2716BTDCTMPLBattery Discharge Temperature Limits20-2060C
17TOB09PDVAPE-Z2717BTENDCVBattery End of Discharge Voltage3.02.03.5V
18TOB09PDVAPE-Z2718BTMXCHCBattery Maximum Charging Current242030mA
19TOB09PDVAPE-Z2719BTMXDCC

Battery Maximum Discharging Current

270024003000mA
20TOB09PDVAPE-Z2720BTULCHVBattery Upper Limits Charging Voltage4.24.14.3V
21TOB09PDVAPE-Z2721PDUVORPDU Voltage Operating Range3.73.24.2V
22TOB09PDVAPE-Z2722PDUCORPDU Current Operating Range12008501800mA
23TOB09PDVAPE-Z2723PDUWTORPDU Wattage Operating Range757080W
24TOB09PDVAPE-Z2724PDUTCTOFPDU Temperature Cut-off705565C
25TOB09PDVAPE-Z2725AIRFLRTAirflow Rate720700740L/min
26TOB09PDVAPE-Z2726PDUCRCOFPDU Current Cut-off352050mA
27TOB09PDVAPE-Z2727INHAERTInhaled Aerosol Temperature373540C
28TOB09PDVAPE-Z2728VENTLTNVentilation504060%
29TOB09PDVAPE-Z2729ELQDVISCE-Liquid Viscosity500751130mPa/s
30TOB09PDVAPE-Z2730ELQDVOLE-liquid Volume6010120mL
31TOB09PDVAPE-Z2731PNUMCNCParticle Number Concentration5001081010/cm3
32TOB09PDVAPE-Z2732CTMDDIAMCount Median Diameter200150250nm
33TOB09PDVAPE-Z2733PM2.5Particulate Matter 2.5251235ug/m3
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Finally, the Tobacco Product Testing (PT) domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only one replicate per parameter is shown. Note that PTREPNUM (repetition number) =1 for all rows. 

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pt.xpt

RowSTUDYIDDOMAINSPTOBIDPTSEQPTREFIDPTTESTCDPTTESTPTTSTCNDPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU

PTREPNUM

1TOB09PTVAPE-Z27

1


DRWRSTDraw Resistance
DESIGN PARAMETER TESTING
91mm H2O9191mm H2O1
2TOB09PTVAPE-Z272
PUFCNTPuff Count
DESIGN PARAMETER TESTING
309
309309
1
3TOB09PTVAPE-Z273
CRTVOLCartridge Volume
DESIGN PARAMETER TESTING
3.09mL3.093.09mL1
4TOB09PTVAPE-Z274
HTELNUMNumber of Heating Elements
DESIGN PARAMETER TESTING
1
11
1
5TOB09PTVAPE-Z275
HTELGTHHeating Element Length
DESIGN PARAMETER TESTING
2.97mm2.972.97mm1
6TOB09PTVAPE-Z276
HTEDIAMHeating Element Diameter
DESIGN PARAMETER TESTING
3.05mm3.053.05mm

1

7TOB09PTVAPE-Z277
HTELRSTHeating Element Resistance
DESIGN PARAMETER TESTING
0.77ohm0.770.77ohm1
8TOB09PTVAPE-Z278
HTELRNGHeating Element Range
DESIGN PARAMETER TESTING
174C174174C1
9TOB09PTVAPE-Z279
HTELCFGHeating Element Configuration
DESIGN PARAMETER TESTING
SPIRAL
SPIRALSPIRAL
1
10TOB09PTVAPE-Z2710
BTVLTORG

Battery Voltage Operating Range


DESIGN PARAMETER TESTING
4.6V4.64.6V1
11TOB09PTVAPE-Z2711
BTCRTORG

Battery Current Operating Range


DESIGN PARAMETER TESTING
997mAh997997mAh1
12TOB09PTVAPE-Z2712
BATCAPCBattery Capacity
DESIGN PARAMETER TESTING
1112mAh11121112mAh1
13TOB09PTVAPE-Z2713
BATNOMV

Battery Nominal Voltage


DESIGN PARAMETER TESTING
4.18V4.184.18V1
14TOB09PTVAPE-Z2714
BTCRTRTBattery Current Rating
DESIGN PARAMETER TESTING
2488mA24882488mA1
15TOB09PTVAPE-Z2715
BTCHTPLBattery Charging Temperature Limits
DESIGN PARAMETER TESTING
198C198198C1
16TOB09PTVAPE-Z2716
BTDCTMPLBattery Discharge Temperature Limits
DESIGN PARAMETER TESTING
19C1919C1
17TOB09PTVAPE-Z2717
BTENDCVBattery End of Discharge Voltage
DESIGN PARAMETER TESTING
3.03V3.033.03V1
18TOB09PTVAPE-Z2718
BTMXCHCBattery Maximum Charging Current
DESIGN PARAMETER TESTING
23.5mA23.523.5mA1
19TOB09PTVAPE-Z2719
BTMXDCC

Battery Maximum Discharging Current


DESIGN PARAMETER TESTING
2696mA26962696mA1
20TOB09PTVAPE-Z2720
BTULCHVBattery Upper Limits Charging Voltage
DESIGN PARAMETER TESTING
4.21V4.214.21V1
21TOB09PTVAPE-Z2721
PDUVORPDU Voltage Operating Range
DESIGN PARAMETER TESTING
3.65V3.653.65V1
22TOB09PTVAPE-Z2722
PDUCORPDU Current Operating Range
DESIGN PARAMETER TESTING
1202mA12021202mA1
23TOB09PTVAPE-Z2723
PDUWTORPDU Wattage Operating Range
DESIGN PARAMETER TESTING
75W7575W1
24TOB09PTVAPE-Z2724
PDUTCTOFPDU Temperature Cut-off
DESIGN PARAMETER TESTING
69.9C69.969.9C1
25TOB09PTVAPE-Z2725
AIRFLRTAirflow Rate
DESIGN PARAMETER TESTING
727L/min727727L/min1
26TOB09PTVAPE-Z2726
PDUCRCOFPDU Current Cut-off
DESIGN PARAMETER TESTING
34.8mA34.834.8mA1
27TOB09PTVAPE-Z2727
INHAERTInhaled Aerosol Temperature
DESIGN PARAMETER TESTING
36.9C36.936.9C1
28TOB09PTVAPE-Z2728
VENTLTNVentilation
DESIGN PARAMETER TESTING
51%5151%1
29TOB09PTVAPE-Z2729
ELQDVISCE-Liquid ViscosityTest performed at 20 degrees CelsiusDESIGN PARAMETER TESTING
496mPa/s496496mPa/s1
30TOB09PTVAPE-Z2730
ELQDVOLE-liquid Volume
DESIGN PARAMETER TESTING
60.1mL60.160.1mL1
31TOB09PTVAPE-Z2731
PNUMCNCParticle Number Concentration
DESIGN PARAMETER TESTING
511/cm3511511/cm31
32TOB09PTVAPE-Z2732
CTMDDIAMCount Median Diameter
DESIGN PARAMETER TESTING
202nm202202nm1
33TOB09PTVAPE-Z2733
PM2.5Particulate Matter 2.5
DESIGN PARAMETER TESTING
24.4ug/m324.424.4ug/m31
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