FDA.reportPublic FDA data

ACTtrac®

Primary DI
00613994495167
Brand
ACTtrac®
Company
MEDTRONIC, INC.
Model
31363
Device description
CONSOLE 31363 ACTTRAC HEPARIN MNGMNT 13L
Published
2016-05-02
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
00613994495167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994495167006139944951676139944951670613994495167

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
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius65 Degrees Celsius

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
00199150062911N/AAFR-002132026-09-04
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000135478ACT Plus®MEDTRONIC, INC.GKN2018-11-29
00763000135461ACTtrac®MEDTRONIC, INC.GKN2018-10-25
00721902932946ACT Plus®MEDTRONIC, INC.GKN2016-09-04
00643169178410ACT Plus®MEDTRONIC, INC.GKN2016-09-04
00721902793066ACT Plus®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