FORA

GUDID 00816042010200

Blood Glucose Test Strips

FORA CARE INC.

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• Primary Device ID: 00816042010200
• NIH Device Record Key: 62583c33-980c-40a9-bad1-da14e33adae5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORA
• Version Model Number: V10/D10/D20
• 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	00816042010200 [Primary]
GS1	80816042010206 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091814

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2016-12-20

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