CLOTtrac®

GUDID 20613994923343

BOXED 550-12 CLOTTRAC HTC CONTROL

MEDTRONIC, INC.

Multiple coagulation factor IVD, control
Primary Device ID20613994923343
NIH Device Record Keyf6f53dec-291a-4218-89e5-b3c9aee929f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLOTtrac®
Version Model Number550-12
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count15
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C.

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994923349 [Unit of Use]
GS120613994923343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JBPACTIVATED WHOLE BLOOD CLOTTING TIME

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 Date2016-06-18

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00763000180133 - Sprint Quattro Secure S™2024-11-12 LEAD 6935M49 US DF4 RCMCRD

Trademark Results [CLOTtrac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLOTTRAC
CLOTTRAC
85769854 4328450 Live/Registered
Medtronic, Inc.
2012-11-02
CLOTTRAC
CLOTTRAC
74059073 1640189 Dead/Cancelled
HemoTec, Inc.
1990-05-15

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