FDA.reportPublic FDA data

NA

Primary DI
00613994416551
Brand
NA
Company
MEDTRONIC, INC.
Model
55096
Device description
CONTROL 55096 PROFICIENCY KIT
Published
2016-04-30
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
K940426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940426000MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMERMedtronic Hemotec, Inc.1994-09-20GKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994416551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994416551006139944165516139944165510613994416551

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
Storage Environment Temperature2 Degrees Celsius25 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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

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
00613994495167ACTtrac®MEDTRONIC, INC.GKN2016-05-02
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