PROTEK Duo

GUDID 00814112020166

29 Fr x 46 cm veno-venous dual lumen cannula with introducer

CARDIACASSIST, INC.

Mobile extracorporeal gas exchange system catheter kit
Primary Device ID00814112020166
NIH Device Record Key6b7c5b5f-18f4-4ea2-9ff6-64c17143969d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROTEK Duo
Version Model Number5140-4629
Company DUNS948683941
Company NameCARDIACASSIST, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-03
Device Publish Date2015-10-10

On-Brand Devices [PROTEK Duo]

00814112020173TandemHeart blood pump kit with veno-venous cannula
0081411202016629 Fr x 46 cm veno-venous dual lumen cannula with introducer

Trademark Results [PROTEK Duo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROTEK DUO
PROTEK DUO
86934746 5131790 Live/Registered
CardiacAssist, Inc.
2016-03-09

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