HeartsCare C1 Plus Multi-Functional Monitoring System

GUDID 00850014861575

Hearts Bio, Inc.

Multiple clinical chemistry analyser IVD, home-use

• Primary Device ID: 00850014861575
• NIH Device Record Key: 34750ef0-1ce6-4197-8625-d12226a9bf56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartsCare C1 Plus Multi-Functional Monitoring System
• Version Model Number: TD-4289
• Company DUNS: 085509873
• Company Name: Hearts Bio, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014861575 [Primary]

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: 2025-07-10
• Device Publish Date: 2025-07-02

On-Brand Devices [HeartsCare C1 Plus Multi-Functional Monitoring System]

• 00850014861056: TD-4289
• 00850014861575: TD-4289