HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX)

GUDID 00850014861629

Hearts Bio, Inc.

Glucose IVD, kit, electrometry

• Primary Device ID: 00850014861629
• NIH Device Record Key: f2b65b01-b6d7-4a7b-aacd-4adbcd50c2f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX)
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850014861629 [Primary]

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

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: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by Hearts Bio, Inc.

• 00850014861056 - HeartsCare C1 Plus Multi-Functional Monitoring System: 2025-04-08
• 00850014861629 - HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX): 2025-04-08
• 00850014861629 - HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX): 2025-04-08
• 00850014861407 - HeartsCare LACTATE TEST STRIPS (10PCS/BOX): 2024-07-16
• 00850014861537 - HeartsCare LACTATE TEST STRIPS (25PCS/BOX): 2024-07-16
• 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