HeartsCare LACTATE TEST STRIPS (25PCS/BOX)

GUDID 00850014861537

Hearts Bio, Inc.

Lactate IVD, reagent

• Primary Device ID: 00850014861537
• NIH Device Record Key: f54072ce-525e-40b3-bfc9-26d6c77049f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartsCare LACTATE TEST STRIPS (25PCS/BOX)
• Version Model Number: TD-4289
• Company DUNS: 085509873
• Company Name: Hearts Bio, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00850014861537 [Primary]

FDA Product Code

• KHP: Acid, Lactic, Enzymatic Method

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: 2024-07-16
• Device Publish Date: 2024-07-08

Devices Manufactured by Hearts Bio, Inc.

• 00850014861407 - HeartsCare LACTATE TEST STRIPS (10PCS/BOX): 2024-07-16
• 00850014861537 - HeartsCare LACTATE TEST STRIPS (25PCS/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