Medibio TD-4277 Blood Glucose Monitoring System

GUDID 00850014981013

MEDIBIO USA LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00850014981013
• NIH Device Record Key: 57bcaacd-ea37-4b36-8cf1-82fe9227df2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medibio TD-4277 Blood Glucose Monitoring System
• Version Model Number: TD-4277
• Company DUNS: 012481654
• Company Name: MEDIBIO USA LLC
• 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: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014981013 [Primary]

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: 2020-01-31
• Device Publish Date: 2020-01-23

Devices Manufactured by MEDIBIO USA LLC

• 00850014981051 - Medibio TD-4277 Blood Glucose Test Strips 50pcs: 2020-02-03
• 00850014981006 - MediBio TD-3140 Blood Pressure Monitor: 2020-01-31
• 00850014981013 - Medibio TD-4277 Blood Glucose Monitoring System: 2020-01-31
• 00850014981013 - Medibio TD-4277 Blood Glucose Monitoring System: 2020-01-31
• 00850014981020 - MediBio TD-8255 Fingertip Pulse Oximeter: 2020-01-31
• 00850014981037 - MediBio TD-2555 Weight Scale: 2020-01-31