Fresh Test 47102056

GUDID G219471020561

Fresh Test Plain Dextrose 75g Powder Glucose Tolerance Test

Fresh Test, LLC

Glucose monitoring system IVD, point-of-care
Primary Device IDG219471020561
NIH Device Record Key0a603fef-2e5c-4085-bdeb-f98c86a2f049
Commercial Distribution StatusIn Commercial Distribution
Brand NameFresh Test
Version Model NumberPlain Dextrose 75g Powder
Catalog Number47102056
Company DUNS051998960
Company NameFresh Test, LLC
Device Count1
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 Datefalse
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
HIBCCG219471020561 [Primary]
HIBCCG219471020562 [Package]
Package: MASTER CARTON [400 Units]
In Commercial Distribution

FDA Product Code

MRVDrink, Glucose Tolerance

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-16
Device Publish Date2025-04-08

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