Pet Gluco

GUDID 00816042010842

Blood Glucose Monitoring System

FORA CARE INC.

Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use

• Primary Device ID: 00816042010842
• NIH Device Record Key: 51fca062-5eec-47bf-90ec-895250bca608
• 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: 1
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00816042010842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101635

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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