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Info
titleTobacco domains

DI = TO for Tobacco Product Identifiers and Descriptors

SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier

DO/DU = Tobacco Product Design Parameters (PD)

LB = Tobacco Product Testing (PT) - [Would Findings be better?]

This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Electronic Nicotine Delivery System (ENDS) (Vapes). There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco product Premarket Authorization (PMTA) and Substantial Equivalence pathways. The applicant submitting for SE and PMTAs may include test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

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Dataset wrap
Namept
Rowcaps
Rows 1-32:Show the tobacco design parameter specification test and the result in ORRES (needs populated).
Row 28:Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test.
Dataset2
RowSTUDYIDDOMAINSPTOBIDTTSEQPTSEQTTREFIDPTREFIDTTTESTCDPTTESTCDTTTESTPTTESTTTTSTCNDPTTSTCNDTTCATPTCATTTSCATPTSCATTTORRESPTORRESTTORRESUPTORRESUTTSTRESCPTSTRESCTTSTRESNPTSTRESNTTSTRESUPTSTRESU
1TOB09PTVAPE-Z27

1


DRWRSTDraw Resistance 
DESIGN PARAMETER SPECIFICATION TEST RESULT

mm H2O

mm H2O
2TOB09PTVAPE-Z272
PUFCNTPuff count (for full tank/cartridge)
DESIGN PARAMETER SPECIFICATION TEST RESULT

NUMBER COUNT

NUMBER COUNT
3TOB09PTVAPE-Z273
CRTVOLCartridge volume
DESIGN PARAMETER SPECIFICATION TEST RESULT

mL

mL
4TOB09PTVAPE-Z274
HTELNUMNumber of heating elements
DESIGN PARAMETER SPECIFICATION TEST RESULT

NUMBER COUNT

NUMBER COUNT
5TOB09PTVAPE-Z275
HTELGTHHeating element length
DESIGN PARAMETER SPECIFICATION TEST RESULT

mm

mm
6TOB09PTVAPE-Z276
HTELRSTHeating element resistance
DESIGN PARAMETER SPECIFICATION TEST RESULT

ohm

ohm
7TOB09PTVAPE-Z277
HTELRNGHeating element range
DESIGN PARAMETER SPECIFICATION TEST RESULT

C

C
8TOB09PTVAPE-Z278
HTELCFGHeating element configuration
DESIGN PARAMETER SPECIFICATION TEST RESULT





9TOB09PTVAPE-Z279
BTVLTORGBattery voltage operating range
DESIGN PARAMETER SPECIFICATION TEST RESULT

V

V
10TOB09PTVAPE-Z2710
BTCRTORGBattery current operating range
DESIGN PARAMETER SPECIFICATION TEST RESULT

mAh

mAh
11TOB09PTVAPE-Z2711
BATCAPCBattery capacity
DESIGN PARAMETER SPECIFICATION TEST RESULT

mAh

mAh
12TOB09PTVAPE-Z2712
BATNOMVBattery nominal voltage
DESIGN PARAMETER SPECIFICATION TEST RESULT

V

V
13TOB09PTVAPE-Z2713
BTCRTRTBattery Current Rating
DESIGN PARAMETER SPECIFICATION TEST RESULT

mA


14TOB09PTVAPE-Z2714
BTCHTPLBattery Charging Temperature Limits
DESIGN PARAMETER SPECIFICATION TEST RESULT

C


15TOB09PTVAPE-Z2715
BTDCTMPLBattery Discharge Temperature Limits
DESIGN PARAMETER SPECIFICATION TEST RESULT

C


16TOB09PTVAPE-Z2716
BTENDCVBattery end of discharge voltage
DESIGN PARAMETER SPECIFICATION TEST RESULT

V


17TOB09PTVAPE-Z2717
BTMXCHCBattery maximum charging current
DESIGN PARAMETER SPECIFICATION TEST RESULT

mA


18TOB09PTVAPE-Z2718
BTMXDCCBattery maximum discharging current
DESIGN PARAMETER SPECIFICATION TEST RESULT

mA


19TOB09PTVAPE-Z2719
BTULCHVBattery upper limits charging voltage
DESIGN PARAMETER SPECIFICATION TEST RESULT

V


20TOB09PTVAPE-Z2720
PDUVORPower Delivery Unit (PDU) voltage operating range
DESIGN PARAMETER SPECIFICATION TEST RESULT

V


21TOB09PTVAPE-Z2721
PDUCORPDU current operating range
DESIGN PARAMETER SPECIFICATION TEST RESULT

mA


22TOB09PTVAPE-Z2722
PDUWTORPDU wattage operating range
DESIGN PARAMETER SPECIFICATION TEST RESULT

W


23TOB09PTVAPE-Z2723
PDUTCTOFPDU temperature cut-off (if applicable)
DESIGN PARAMETER SPECIFICATION TEST RESULT

C


24TOB09PTVAPE-Z2724
AIRFLRTAirflow rate
DESIGN PARAMETER SPECIFICATION TEST RESULT

L/min


25TOB09PTVAPE-Z2725
PDUCRCOFPDU current cut-off (if applicable)
DESIGN PARAMETER SPECIFICATION TEST RESULT

mA


26TOB09PTVAPE-Z2726
INHAERTInhaled aerosol temperature
DESIGN PARAMETER SPECIFICATION TEST RESULT

C


27TOB09PTVAPE-Z2727
VENTLTNVentilation
DESIGN PARAMETER SPECIFICATION TEST RESULT

%


28TOB09PTVAPE-Z2728
ELQDVISCE-Liquid viscosityTest performed at 20 degrees CelsiusDESIGN PARAMETER SPECIFICATION TEST RESULT





29TOB09PTVAPE-Z2729
ELQDVOLE-liquid volume
DESIGN PARAMETER SPECIFICATION TEST RESULT

mL


30TOB09PTVAPE-Z2730
PNUMCNCParticle number concentration
DESIGN PARAMETER SPECIFICATION TEST RESULT

#/cm3


31TOB09PTVAPE-Z2731
CTMDDIAMCount median diameter
DESIGN PARAMETER SPECIFICATION TEST RESULT

nm


32TOB09PTVAPE-Z2732
PMPM 2.5
DESIGN PARAMETER SPECIFICATION TEST RESULT

ug/m3