HeartsCare C1 multi-functional monitoring system

GUDID 00850014861049

Hearts Bio, Inc.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent

• Primary Device ID: 00850014861049
• NIH Device Record Key: ac1da8d0-61bd-427a-9303-df23d90c9c4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartsCare C1 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	00850014861049 [Primary]

FDA Product Code

• CHH: Enzymatic Esterase--Oxidase, Cholesterol
• 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: 2022-02-03
• Device Publish Date: 2022-01-26

Devices Manufactured by Hearts Bio, Inc.

• 00850014861353 - HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX): 2023-08-16
• 00850014861360 - HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX): 2023-08-16
• 00850014861049 - HeartsCare C1 multi-functional monitoring system: 2022-02-03
• 00850014861049 - HeartsCare C1 multi-functional monitoring system: 2022-02-03