BIOCOACH Blood Glucose Test Strips 50 Pack (Foil) S5640936

GUDID 00850017460287

50s

AMVENTUREX, INC.

Glucose monitoring system IVD, home-use
Primary Device ID00850017460287
NIH Device Record Keyb623091f-8d79-465e-b736-96132e04f67d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOCOACH Blood Glucose Test Strips 50 Pack (Foil)
Version Model NumberS5640936
Catalog NumberS5640936
Company DUNS117225590
Company NameAMVENTUREX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100850017460287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-08
Device Publish Date2023-05-31

Devices Manufactured by AMVENTUREX, INC.

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