EasySampler, No Substrate Kit, 10 Tubes QT04208

GUDID 00850010197104

KIT, EASYSAMPLER, NO SUBSTRATE, 10 SAMPLE

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD
Primary Device ID00850010197104
NIH Device Record Key0911e818-690f-425d-956f-4dc0bce42e81
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasySampler, No Substrate Kit, 10 Tubes
Version Model NumberQT04208
Catalog NumberQT04208
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
GS100850010197104 [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

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