Home GUDID 00850014861407 HeartsCare LACTATE TEST STRIPS (10PCS/BOX)
Primary DI 00850014861407
Brand HeartsCare LACTATE TEST STRIPS (10PCS/BOX)
Company Hearts Bio, Inc.
Model TD-4289
Published 2024-07-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name KHP Acid, Lactic, Enzymatic Method
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KHP Acid, Lactic, Enzymatic Method Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850014861407 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850014861407 00850014861407 850014861407 0850014861407
GMDN Terms# Term, Definition table Term Definition Lactate IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of lactate in a clinical specimen.
Regulatory Flags# DUNS number 085509873 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850014861834 heartscare Total Cholesterol Test Strip (10pcs/box) TD-4289 2026-04-17 00850014861629 HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX) TD-4289 2025-03-31 00850014861681 heartscare B-Ketone Test Strips (10pcs/Box) TD-4289 2025-10-01 00850014861575 HeartsCare C1 Plus Multi-Functional Monitoring System TD-4289 2025-07-02 00850014861056 HeartsCare C1 Plus Multi-Functional Monitoring System TD-4289 2025-03-31 00850014861537 HeartsCare LACTATE TEST STRIPS (25PCS/BOX) TD-4289 2024-07-08 00850014861353 HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX) TD-4289 2023-08-08 00850014861360 HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) TD-4289 2023-08-08 00850014861049 HeartsCare C1 monitoring system TD-4289 2022-01-26 00850014861346 HeartsCare C1 Total Cholesterol Test Strip (10pcs/box) TD-4289 2022-04-11
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816042014543 FORA FORA CARE INC. KHP 2025-05-06 80816042014549 FORA FORA CARE INC. KHP 2025-05-06 00850014861537 HeartsCare LACTATE TEST STRIPS (25PCS/BOX) Hearts Bio, Inc. KHP 2024-07-08 05700699460509 SC90 50 BG, LYT, MET, OXI + QC Radiometer Medical ApS KHP 2024-07-01 00380740158392 ARCHITECT ABBOTT IRELAND KHP 2024-01-24 00380740158408 Alinity ABBOTT IRELAND KHP 2024-01-24 00816042014505 FORA FORA CARE INC. KHP 2023-10-31 00850014861360 HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) Hearts Bio, Inc. KHP 2023-08-08 06971674866756 BIOBASE Biobase Biodustry(Shandong)Co., Ltd. KHP 2023-07-22 06971674866763 BIOBASE Biobase Biodustry(Shandong)Co., Ltd. KHP 2023-07-22 06971674866770 BIOBASE Biobase Biodustry(Shandong)Co., Ltd. KHP 2023-07-22 00630414610979 Atellica CH Lactate_3 Siemens Healthcare Diagnostics Inc. KHP 2023-05-10 00630414305066 Atellica CH Lactate_3 Siemens Healthcare Diagnostics Inc. KHP 2023-05-10 10385480408131 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 00385480408141 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 00385480408158 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 00385480626248 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 10054749005502 i-STAT ABBOTT POINT OF CARE INC. KHP 2020-10-05 00054749005505 i-STAT ABBOTT POINT OF CARE INC. KHP 2020-10-05 00630414606460 epoc Host2 Epocal Inc KHP 2020-07-15 00630414286143 RAPIDPoint® 500e Blood Gas System Siemens Healthcare Diagnostics Inc. KHP 2020-04-15 05700699441362 S8377 REF 944-136 *6 Cleaning solution Met II Solution Radiometer Medical ApS KHP 2018-09-21 05700699055903 Disposable Waste Container D512 REF 905-590 Radiometer Medical ApS KHP 2018-09-21 05700699058027 Disposable Waste Container D513 REF 905-802 Radiometer Medical ApS KHP 2018-09-21 05700699059178 REF 905-917 ABL90 FLEX sBOX Radiometer Medical ApS KHP 2018-09-21 05700699059185 905-918 ABL90 FLEX flush device Radiometer Medical ApS KHP 2018-09-21 05700699059567 REF 905-956 ABL90 FLEX sBOX PLUS Radiometer Medical ApS KHP 2018-09-21 05700699250476 925-047 ABL90 FLEX inlet clip Radiometer Medical ApS KHP 2018-09-21 05700699439062 S5362 REF 943-906 Radiometer Medical ApS KHP 2018-09-21 05700699441232 Cleaning Solution with additive S7375 REF 944-123 Radiometer Medical ApS KHP 2018-09-21