KIT, LACTOSE, EASYSAMPLER, 7T, #8024 QT04266

GUDID 00850010197722

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD
Primary Device ID00850010197722
NIH Device Record Key0ae543d9-d68b-476c-9c86-f7cc7b15505f
Commercial Distribution StatusIn Commercial Distribution
Brand NameKIT, LACTOSE, EASYSAMPLER, 7T, #8024
Version Model NumberQT04266
Catalog NumberQT04266
Company DUNS874498744
Company NameQUINTRON INSTRUMENT COMPANY, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100850010197722 [Primary]

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

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
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.