ACTtrac®

GUDID 00613994495167

CONSOLE 31363 ACTTRAC HEPARIN MNGMNT 13L

MEDTRONIC, INC.

Multiple coagulation factor IVD, control
Primary Device ID00613994495167
NIH Device Record Key2bd25c88-043e-468b-b22b-e34b3fa71b42
Commercial Distribution StatusIn Commercial Distribution
Brand NameACTtrac®
Version Model Number31363
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 TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994495167 [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 Date2016-05-02

On-Brand Devices [ACTtrac®]

00613994495167CONSOLE 31363 ACTTRAC HEPARIN MNGMNT 13L
00643169178434CONSOLE 31363 ACTTRAC CE IVDD
00763000135461CONSOLE 31363 ACTTRAC CE IVDD NON-ROHS

Trademark Results [ACTtrac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACTTRAC
ACTTRAC
74716595 2076253 Live/Registered
Medtronic, Inc.
1995-08-16

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