FORA

GUDID 80816042013573

Blood Glucose Test Strips

FORA CARE INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 80816042013573
• NIH Device Record Key: a9224fed-8677-4cfd-a909-d8403c74460c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORA
• Version Model Number: GTel/Test N'GO Advance/Test N'GO Advance Voice/Goj
• Company DUNS: 004340807
• Company Name: FORA CARE INC.
• Device Count: 50
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00816042013577 [Primary]
GS1	80816042013573 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161738

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

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: 2020-12-30
• Device Publish Date: 2020-12-22

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