VTRUST

GUDID 00816042013836

Handheld Pulse Oximeter

FORA CARE INC.

Pulse oximeter, battery-powered

• Primary Device ID: 00816042013836
• NIH Device Record Key: 9bfb4288-b302-4e17-9df6-ef6892ad3f85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VTRUST
• Version Model Number: TD-8201
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816042013836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101012

FDA Product Code

• DQA: Oximeter

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: 2020-04-06
• Device Publish Date: 2020-03-27

Devices Manufactured by FORA CARE INC.

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• 80816042015065 - FORA: 2024-10-09 Blood Ketone Test Strips
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• 80816042015256 - FORA: 2024-10-01 Uric Acid Test Strip
• 80816042015188 - FORA: 2024-04-29 Blood Ketone Test Strips
• 00816042014611 - FORA: 2024-03-11 Multi-Functional Monitoring System
• 00816042015083 - FORA: 2024-03-06 Blood Pressure Monitoring System
• 00816042014963 - FORA: 2024-01-24 Blood Pressure Monitoring System