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

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
00763000354466Symplicity Spyral™RDN0162023-11-30
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02

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