EASYSAMPLER ASM, 793275 QT01665

GUDID 00850010197920

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD
Primary Device ID00850010197920
NIH Device Record Key90427f15-ccfd-466f-b431-c541889f792b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEASYSAMPLER ASM, 793275
Version Model NumberQT01665
Catalog NumberQT01665
Company DUNS874498744
Company NameQUINTRON INSTRUMENT COMPANY, INC.
Device Count50
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 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
GS100850010197630 [Primary]
GS100850010197920 [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 Date2023-03-24
Device Publish Date2023-03-16

Devices Manufactured by QUINTRON INSTRUMENT COMPANY, INC.

00850010197982 - SUGAR, Rx, LACTULOSE, 10 GM SYRUP, USP2024-03-26
00850010197937 - LOANER ALVEOVAC EXTRACTOR2023-03-27
00850010197944 - EXTRACTOR REPAIR2023-03-27
00850010197920 - EASYSAMPLER ASM, 7932752023-03-24
00850010197920 - EASYSAMPLER ASM, 7932752023-03-24
00850010197906 - BT GC LOANER SC2023-03-24
00850010197913 - BREATHTRACKER SERIES REPAIR2023-03-24
00850010197005 - AlveoSampler2023-03-23 KIT, ALVEOSAMPLER ONLY, NO SUBSTRATE
00850010197012 - GaSampler Bag, Single-Patient2023-03-23 BAG, COLLECTION, GASAMPLER, SINGLE PATIENT

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