FDA.reportPublic FDA data

ACT Plus®

Primary DI
00763000135478
Brand
ACT Plus®
Company
MEDTRONIC, INC.
Model
ACTSC
Device description
SCANNER ACTSC FINISHED ACT PLUS C4 NROHS
Published
2018-11-29
Public version status
New
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
00763000135478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000135478007630001354787630001354780763000135478

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation timer IVDAn electronic device that is used to measure, indicate, and/or record the length of time taken for plasma or a whole blood sample to form a clot following the initiation of a reaction, typically as part of in vitro coagulation studies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius49 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
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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