HEPtrac®

GUDID 00613994615633

DEVICE 313-51 HEPTRAC ELEC QLT CNTRL CEM

MEDTRONIC, INC.

Coagulation timer IVD
Primary Device ID00613994615633
NIH Device Record Key74190b82-e470-495c-89e8-d5d73a92687d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEPtrac®
Version Model Number313-51
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 -50 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -50 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -50 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -50 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994615633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

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 Date2016-09-04

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Trademark Results [HEPtrac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEPTRAC
HEPTRAC
74716335 2236970 Live/Registered
Medtronic, Inc.
1995-08-16

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