metene BLOOD GLUCOSE MONITORING SYSTEM

GUDID 00739810205885

METENE LIMITED

Glucose analyser IVD, home-use

• Primary Device ID: 00739810205885
• NIH Device Record Key: fcc30ee6-b486-42e0-b3d3-f73e7282ad34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: metene BLOOD GLUCOSE MONITORING SYSTEM
• Version Model Number: TD-4116
• Company DUNS: 117110707
• Company Name: METENE LIMITED
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00739810205885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090188

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: 2020-08-28
• Device Publish Date: 2020-08-20

On-Brand Devices [metene BLOOD GLUCOSE MONITORING SYSTEM]

• 00739810207742: TD-4116
• 00739810205885: TD-4116
• 00850009854018: Lancet 100 Pcs Strip 100 Pcs Control solution 1 Bottle Lancing device 1 Pcs