Home GUDID 20763000558219
CLOTtrac™
Primary DI 20763000558219
Brand CLOTtrac™
Company MEDTRONIC, INC.
Model 550-09
Device description CONT 550-09 CLOTTRAC LR ABN BXD ASY
Published 2026-02-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true
Product Codes# Code, Name table Code Name JBP ACTIVATED WHOLE BLOOD CLOTTING TIME
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JBP Activated Whole Blood Clotting Time Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20763000558219 Package GS1 15 In Commercial Distribution 00763000558215 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 20763000558219 20763000558219 00763000558215 00763000558215 763000558215 0763000558215
GMDN Terms# Term, Definition table Term Definition Multiple coagulation factor IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 10 Degrees Celsius
Regulatory Flags# DUNS number 006261481 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00763000558338 HR HTC MEDTRONIC, INC. JBP 2026-02-23 20763000558332 HR HTC MEDTRONIC, INC. JBP 2026-02-23 00763000558192 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 00763000558208 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 00763000558215 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 00763000558222 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 00763000558239 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 20763000558196 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 20763000558202 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 20763000558226 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 20763000558233 CLOTtrac™ MEDTRONIC, INC. JBP 2026-02-22 B558DP29510 Sonoclot® Coagulation & Platelet Function Analyzer SIENCO, INC. JBP 2023-06-28 20763000433813 LR-ACT MEDTRONIC, INC. JBP 2023-04-08 20763000433844 HR-ACT MEDTRONIC, INC. JBP 2023-04-08 00763000433819 LR-ACT MEDTRONIC, INC. JBP 2023-04-08 00763000433840 HR-ACT MEDTRONIC, INC. JBP 2023-04-08 20763000441450 NA MEDTRONIC, INC. JBP 2023-04-07 00763000441456 NA MEDTRONIC, INC. JBP 2023-04-07 10711234103401 GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) ACCRIVA DIAGNOSTICS HOLDINGS, INC. JBP 2022-01-21 10711234103418 GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR) ACCRIVA DIAGNOSTICS HOLDINGS, INC. JBP 2022-01-21 00711234103404 GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) ACCRIVA DIAGNOSTICS HOLDINGS, INC. JBP 2022-01-21 00711234103411 GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR) ACCRIVA DIAGNOSTICS HOLDINGS, INC. JBP 2022-01-21 20643169730155 N/A MEDTRONIC, INC. JBP 2021-11-12 00643169730151 N/A MEDTRONIC, INC. JBP 2021-11-12 B55880004411 Sonoclot® aiACT Kit SIENCO, INC. JBP 2021-07-19 B55880004421 Sonoclot® aiACT Kit SIENCO, INC. JBP 2021-07-19 B55880004410 Sonoclot® aiACT Kit SIENCO, INC. JBP 2021-07-19 B55880004420 Sonoclot® aiACT Kit SIENCO, INC. JBP 2021-07-19 B55880004111 Sonoclot® gbACT+ Kit SIENCO, INC. JBP 2021-05-26 B55880004121 Sonoclot® gbACT+ Kit SIENCO, INC. JBP 2021-05-26