FORA

GUDID 00816042013102

Ketone Test Strips

FORA CARE INC.

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 00816042013102
• NIH Device Record Key: 9363d55c-7eed-4fd5-aec6-049de493741e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORA
• Version Model Number: Test N'GO Advance/Advance Voice/6 Connect
• Company DUNS: 004340807
• Company Name: FORA CARE INC.
• Device Count: 10
• 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	00816042013102 [Primary]
GS1	80816042013108 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161738

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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: 2018-11-02
• Device Publish Date: 2018-10-02

On-Brand Devices [FORA]

• 00816042013447: Blood Glucose Plus Blood Pressure Monitoring System
• 00816042013430: Ear Thermometer
• 00816042013270: Blood Glucose Test Strips
• 00816042013256: Blood Glucose Test Strips
• 00816042013225: Forehead Thermometer
• 00816042013188: Blood Glucose Monitoring System
• 00816042013171: Multi-Functional Monitoring System
• 00816042013157: Ketone Test Strips
• 00816042013119: Blood Glucose Test Strips
• 00816042013102: Ketone Test Strips
• 00816042013096: Multi-Functional Monitoring System
• 00816042013089: Ketone Test Strips
• 00816042013072: Blood Glucose Test Strips
• 00816042013065: Multi-Functional Monitoring System
• 00816042013058: Blood Pressure Monitoring System
• 00816042012853: Blood Glucose Test Strips
• 00816042012846: Blood Glucose Plus Blood Pressure Monitoring System
• 00816042012716: Blood Glucose Monitoring System
• 00816042012273: Blood Glucose Test Strips
• 00816042012198: Tympanic Thermometer
• 00816042012044: Blood Glucose Plus Blood Pressure Monitoring System
• 00816042012020: Blood Glucose Test Strips
• 00816042011986: Blood Glucose Test Strips
• 00816042011962: Blood Glucose Monitoring System
• 00816042011924: Blood Glucose Test Strips
• 00816042011917: Blood Pressure Monitoring System
• 00816042011764: Fingertip Pulse Oximeter
• 00816042011726: Ear Thermometer
• 00816042011702: Blood Glucose Test Strips
• 00816042011672: Blood Glucose Test Strips
• 00816042011665: Blood Glucose Test Strips
• 00816042011634: Blood Glucose Test Strips
• 00816042011627: Blood Glucose Monitoring System
• 00816042011610: Blood Glucose Test Strips
• 00816042011276: Tympanic Thermometer (Bluetooth)
• 00816042011221: Blood Glucose Test Strips
• 00816042011191: Blood Glucose Monitoring System
• 00816042011139: Blood Glucose Monitoring System
• 00816042011009: Blood Glucose Plus Blood Pressure Monitoring System
• 00816042010972: Blood Glucose Monitoring System
• 00816042010965: Blood Glucose Monitoring System
• 00816042010828: Blood Glucose Test Strips
• 00816042010804: Blood Glucose Monitoring System
• 00816042010675: Blood Glucose Test Strips
• 00816042010200: Blood Glucose Test Strips
• 00816042011788: Blood Pressure Monitoring System
• 00816042013553: Fingertip Pulse Oximeter
• 00816042013331: Multi-Functional Monitoring System
• 00816042013850: Multi-Functional Monitoring System
• 00816042013164: Ketone Test Strips