SUGAR, DEXTROSE (GLUCOSE), 75 GM PACKET QT02300-75-S

GUDID 00850010197746

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD Breath specimen container IVD
Primary Device ID00850010197746
NIH Device Record Keyc4e9238f-6ddc-4a9c-bb42-8a8f03aff1dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUGAR, DEXTROSE (GLUCOSE), 75 GM PACKET
Version Model NumberQT02300-75-S
Catalog NumberQT02300-75-S
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
GS100850010197142 [Primary]
GS100850010197746 [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

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.