GaSampler Kit, Single-Patient, No Substrate QT00892

GUDID 00850010197043

KIT, GASAMPLER SINGLE-PT, NO SUBSTRATE

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD
Primary Device ID00850010197043
NIH Device Record Key762a96e8-177c-438e-b910-2d2376b41daa
Commercial Distribution StatusIn Commercial Distribution
Brand NameGaSampler Kit, Single-Patient, No Substrate
Version Model NumberQT00892
Catalog NumberQT00892
Company DUNS874498744
Company NameQUINTRON INSTRUMENT COMPANY, INC.
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010197043 [Primary]
GS100850010197890 [Unit of Use]

FDA Product Code

NNIContainer, Specimen, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

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