FORA

GUDID 00816042011924

Blood Glucose Test Strips

FORA CARE INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 00816042011924
• NIH Device Record Key: 30b49d4c-9ade-4d4d-8b99-ec7888a8229d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORA
• Version Model Number: TN'G/TN'G Voice
• 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	00816042011924 [Primary]
GS1	80816042011920 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100322

FDA Product Code

• LFR: Glucose Dehydrogenase, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-05

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• 00816042011726: Ear Thermometer
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• 00816042011610: Blood Glucose Test Strips
• 00816042011276: Tympanic Thermometer (Bluetooth)
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• 00816042011191: Blood Glucose Monitoring System
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• 00816042010972: Blood Glucose Monitoring System
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• 00816042011788: Blood Pressure Monitoring System
• 00816042013553: Fingertip Pulse Oximeter
• 00816042013331: Multi-Functional Monitoring System
• 00816042013850: Multi-Functional Monitoring System
• 00816042013164: Ketone Test Strips