HeartsCare C1 multi-functional monitoring system

GUDID 00850014861049

Hearts Bio, Inc.

Glucose monitoring system IVD, home-use
Primary Device ID00850014861049
NIH Device Record Keyac1da8d0-61bd-427a-9303-df23d90c9c4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartsCare C1 multi-functional monitoring system
Version Model NumberTD-4289
Company DUNS085509873
Company NameHearts Bio, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014861049 [Primary]

FDA Product Code

CHHEnzymatic Esterase--Oxidase, Cholesterol
NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-03
Device Publish Date2022-01-26

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
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 system2022-02-03
00850014861049 - HeartsCare C1 multi-functional monitoring system2022-02-03

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