Pro Voice

GUDID 00816042012730

Blood Glucose Monitoring System

FORACARE TEXAS, INC

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

• Primary Device ID: 00816042012730
• NIH Device Record Key: dc6c880e-cc34-440e-9298-1698895dabd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro Voice
• Version Model Number: V9
• Company DUNS: 028662035
• Company Name: FORACARE TEXAS, 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	00816042012730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072039

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-01

On-Brand Devices [Pro Voice]

• 00816042012747: Blood Glucose Test Strips
• 00816042012730: Blood Glucose Monitoring System
• 00816042012723: Blood Glucose Monitoring System