EasySampler, Lactulose Kit, 10 Tubes, Rx QT04205

GUDID 00850010197081

KIT, EASYSAMPLER, Rx, LACTULOSE SIBO 10T

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD
Primary Device ID00850010197081
NIH Device Record Key39d5b916-1288-4e5c-8dd3-b22571329ce0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasySampler, Lactulose Kit, 10 Tubes, Rx
Version Model NumberQT04205
Catalog NumberQT04205
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
GS100850010197081 [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.

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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

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