BIOCOACH Glucose Control Solution L1/L2 S5800382

GUDID 00850017460058

Level 1 & 2

AMVENTUREX, INC.

Glucose monitoring system IVD, home-use
Primary Device ID00850017460058
NIH Device Record Key776adc13-de91-4c07-b893-a2859a20e534
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOCOACH Glucose Control Solution L1/L2
Version Model NumberS5800382
Catalog NumberS5800382
Company DUNS117225590
Company NameAMVENTUREX, INC.
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 Usefalse
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
GS100850017460058 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-05
Device Publish Date2021-12-28

Devices Manufactured by AMVENTUREX, INC.

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