metene Blood Glucose Monitoring System

GUDID 08806128351589

All Medicus Co.,Ltd.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use
Primary Device ID08806128351589
NIH Device Record Keye32b7b97-6e88-42ee-aa55-50d4fee59fe8
Commercial Distribution StatusIn Commercial Distribution
Brand Namemetene Blood Glucose Monitoring System
Version Model NumberAGM-513S
Company DUNS688022826
Company NameAll Medicus Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108806128351589 [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 Date2022-01-03
Device Publish Date2021-12-24

Devices Manufactured by All Medicus Co.,Ltd.

08806128351503 - metene Control Solution2022-01-03
08806128351541 - metene Blood Glucose Test Strip2022-01-03
08806128351565 - metene Blood Glucose Test Meter2022-01-03
08806128351589 - metene Blood Glucose Monitoring System2022-01-03
08806128351589 - metene Blood Glucose Monitoring System2022-01-03

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