FDA.reportPublic FDA data

CLOTtrac®

Primary DI
10885074184880
Brand
CLOTtrac®
Company
MEDTRONIC, INC.
Model
550-08
Device description
CONT 550-08 CLOTTRAC HR ABN BXD ASY 15BX
Published
2016-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JBPACTIVATED WHOLE BLOOD CLOTTING TIME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBPActivated Whole Blood Clotting TimeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923594000CLOTTRAC COAGULATION CONTROLMedtronic Hemotec, Inc.1992-09-21JBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885074184880PrimaryGS10
00885074184883Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088507418488010885074184880
00885074184883008850741848838850741848830885074184883

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C.
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
15
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000558338HR HTCMEDTRONIC, INC.JBP2026-02-23
20763000558332HR HTCMEDTRONIC, INC.JBP2026-02-23
00763000558192CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558208CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558215CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558222CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558239CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558196CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558202CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558219CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558226CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558233CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
B558DP29510Sonoclot® Coagulation & Platelet Function AnalyzerSIENCO, INC.JBP2023-06-28
20763000433813LR-ACTMEDTRONIC, INC.JBP2023-04-08
20763000433844HR-ACTMEDTRONIC, INC.JBP2023-04-08
00763000433819LR-ACTMEDTRONIC, INC.JBP2023-04-08
00763000433840HR-ACTMEDTRONIC, INC.JBP2023-04-08
20763000441450NAMEDTRONIC, INC.JBP2023-04-07
00763000441456NAMEDTRONIC, INC.JBP2023-04-07
10711234103401GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
10711234103418GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
00711234103404GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
00711234103411GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
20643169730155N/AMEDTRONIC, INC.JBP2021-11-12
00643169730151N/AMEDTRONIC, INC.JBP2021-11-12
B55880004411Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004421Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004410Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004420Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004111Sonoclot® gbACT+ KitSIENCO, INC.JBP2021-05-26