GaSampler Bag, Single-Patient QT00830-P

GUDID 00850010197012

BAG, COLLECTION, GASAMPLER, SINGLE PATIENT

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD
Primary Device ID00850010197012
NIH Device Record Keyff504b63-1186-4c30-9617-3f0e15c629b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGaSampler Bag, Single-Patient
Version Model NumberQT00830-P
Catalog NumberQT00830-P
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010197012 [Primary]
GS100850010197739 [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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00850010197012 - GaSampler Bag, Single-Patient2023-03-23BAG, COLLECTION, GASAMPLER, SINGLE PATIENT
00850010197012 - GaSampler Bag, Single-Patient2023-03-23 BAG, COLLECTION, GASAMPLER, SINGLE PATIENT

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