FDA.reportPublic FDA data

ACTtrac®

Primary DI
00763000135461
Brand
ACTtrac®
Company
MEDTRONIC, INC.
Model
31363
Device description
CONSOLE 31363 ACTTRAC CE IVDD NON-ROHS
Published
2018-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKNTimer, clot, automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKNTimer, Clot, AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953870000ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTSMedtronic Vascular1995-10-31GKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000135461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000135461007630001354617630001354610763000135461

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor 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 one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000387020Symplicity G3™RDNG3A2023-11-30
00824846020073NABB10E56R162026-10-01
00643169845893Reveal LINQ™LNQ112020-01-19
00199150032402SenSight™B31030-S2026-09-28
00199150032426SenSight™B31030-D2026-09-28
00763000923709Power CordMCS1621PC2026-09-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000135478ACT Plus®MEDTRONIC, INC.GKN2018-11-29
00721902932946ACT Plus®MEDTRONIC, INC.GKN2016-09-04
00643169178410ACT Plus®MEDTRONIC, INC.GKN2016-09-04
00721902793066ACT Plus®MEDTRONIC, INC.GKN2016-05-02
00613994495167ACTtrac®MEDTRONIC, INC.GKN2016-05-02
00613994416551NAMEDTRONIC, INC.GKN2016-04-30
00613994390714ACT Plus®MEDTRONIC, INC.GKN2016-04-29
00721902932939ACT Plus®MEDTRONIC, INC.GKN2016-04-28
00643169178380ACT Plus®MEDTRONIC, INC.GKN2016-04-28
00643169178434ACTtrac®MEDTRONIC, INC.GKN2016-04-28