ForaCare

GUDID 80816042013887

Blood Glucose Test Strips

FORA CARE INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 80816042013887
• NIH Device Record Key: dd5fdc0c-aa4e-4c4f-8af7-58adf3b3d013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ForaCare
• Version Model Number: GD20
• 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	00816042013881 [Primary]
GS1	80816042013887 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101631

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: 2020-04-14
• Device Publish Date: 2020-04-06

On-Brand Devices [ForaCare]

• 80816042013887: Blood Glucose Test Strips
• 00898939002291: Blood Glucose Monitoring System