metene Blood Glucose Monitoring System

GUDID 08806128351589

All Medicus Co.,Ltd.

Glucose monitoring system IVD, home-use

• Primary Device ID: 08806128351589
• NIH Device Record Key: e32b7b97-6e88-42ee-aa55-50d4fee59fe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: metene Blood Glucose Monitoring System
• Version Model Number: AGM-513S
• Company DUNS: 688022826
• Company Name: All Medicus Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806128351589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170241

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-03
• Device Publish Date: 2021-12-24

Devices Manufactured by All Medicus Co.,Ltd.

• 08806128351503 - metene Control Solution: 2022-01-03
• 08806128351541 - metene Blood Glucose Test Strip: 2022-01-03
• 08806128351565 - metene Blood Glucose Test Meter: 2022-01-03
• 08806128351589 - metene Blood Glucose Monitoring System: 2022-01-03
• 08806128351589 - metene Blood Glucose Monitoring System: 2022-01-03