Pet Gluco

GUDID 00816042010859

Blood Glucose Test Strips

FORA CARE INC.

Glucose IVD, kit, electrometry Glucose IVD, kit, electrometry Glucose IVD, kit, electrometry

• Primary Device ID: 00816042010859
• NIH Device Record Key: 533cc3a7-7899-4d97-8c37-cc73d81f39e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pet Gluco
• Version Model Number: Pet Gluco
• 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	00816042010859 [Primary]
GS1	80816042010855 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101635

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: 2018-09-07
• Device Publish Date: 2018-08-07

On-Brand Devices [Pet Gluco]

• 00816042010859: Blood Glucose Test Strips
• 00816042010842: Blood Glucose Monitoring System