Easy Talk

GUDID 04719871820131

Easy Talk Blood Glucose Monitoring System(Meter Only Kit)

BIOTEST MEDICAL CORPORATION

Glucose analyser IVD, home-use/point-of-care, line-powered

• Primary Device ID: 04719871820131
• NIH Device Record Key: 5baa7ca8-bf0a-4e9e-bf33-eecd31cdd4fe
• Commercial Distribution Discontinuation: 2016-05-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Easy Talk
• Version Model Number: 6277(BZG62277HAA)
• Company DUNS: 658447255
• Company Name: BIOTEST MEDICAL CORPORATION
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	04719871820131 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-02

On-Brand Devices [Easy Talk]

• 04719871820209: Easy Talk Control Solution-Low(Box)
• 04719871820193: Easy Talk Control Solution-Low(Vial)
• 04719871820186: Easy Talk Control Solution-High(Vial)
• 04719871820179: Easy Talk Control Solution-High(Box)
• 04719871820162: Easy Talk Blood Glucose Test Strip(25pc/vial)
• 04719871820155: Easy Talk Blood Glucose Test Strip(25x2/Box)
• 04719871820148: Easy Talk Blood Glucose Monitoring System(Glucose Meter)
• 04719871820131: Easy Talk Blood Glucose Monitoring System(Meter Only Kit)