FDA.reportPublic FDA data

HeartsCare C1 Plus Multi-Functional Monitoring System

Primary DI
00850014861056
Brand
HeartsCare C1 Plus Multi-Functional Monitoring System
Company
Hearts Bio, Inc.
Model
TD-4289
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CHHEnzymatic Esterase--Oxidase, Cholesterol
JINNitroprusside, Ketones (Urinary, Non-Quant.)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014861056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014861056008500148610568500148610560850014861056

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, home-useAn electrically-powered instrument intended to be used by a layperson in the home or similar environment for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen; it does not include test reagents or disposable items. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
085509873
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014861834heartscare Total Cholesterol Test Strip (10pcs/box)TD-42892026-04-17
00850014861629HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX)TD-42892025-03-31
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)TD-42892025-10-01
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemTD-42892025-07-02
00850014861407HeartsCare LACTATE TEST STRIPS (10PCS/BOX)TD-42892024-07-08
00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)TD-42892024-07-08
00850014861353HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)TD-42892023-08-08
00850014861360HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX)TD-42892023-08-08
00850014861049HeartsCare C1 monitoring systemTD-42892022-01-26
00850014861346HeartsCare C1 Total Cholesterol Test Strip (10pcs/box)TD-42892022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-04
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIN2022-04-13
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05