ACT Plus®

GUDID 00721902932939

INSTRUMENT EACT100 ACT PLUS 110V

MEDTRONIC, INC.

Coagulation timer IVD
Primary Device ID00721902932939
NIH Device Record Keyd7e2c373-3f7e-4fe8-adb3-b36fd9380ce3
Commercial Distribution StatusIn Commercial Distribution
Brand NameACT Plus®
Version Model NumberEACT100
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100721902932939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKNTimer, clot, automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-28

On-Brand Devices [ACT Plus®]

00613994390714SCANNER ACTSC FINISHED ACT PLUS C4
00643169178410INSTRUMENT ACT200 ACT PLUS 220VN1 IVDD
00643169178380INSTRUMENT ACT100 ACT PLUS 110V IVDD
00721902932946INSTRUMENT RACT100 ACT PLUS 110V RECOND
00721902932939INSTRUMENT EACT100 ACT PLUS 110V
00721902793066INSTRUMENT ACT100 ACT PLUS 110V
00763000135478SCANNER ACTSC FINISHED ACT PLUS C4 NROHS

Trademark Results [ACT Plus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACT PLUS
ACT PLUS
78234560 2849787 Live/Registered
Medtronic, Inc.
2003-04-07
ACT PLUS
ACT PLUS
73285012 1196775 Dead/Cancelled
STSC, Inc.
1980-11-07

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