ProtekSolo

GUDID 00814112020449

24 Fr x 60 cm venous cannula with 21 Fr Introducer

CARDIACASSIST, INC.

Cardiopulmonary bypass cannula, venous
Primary Device ID00814112020449
NIH Device Record Key5862edb8-6542-4ae4-9373-c37f99269fc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtekSolo
Version Model Number5140-6024
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com
Phone18003737421
Emailgjohnson@tandemlife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020449 [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 Date2017-01-27

On-Brand Devices [ProtekSolo]

00814112020463Three 25 cm Dilators (14 Fr, 18 Fr, and 22 Fr)
0081411202044924 Fr x 60 cm venous cannula with 21 Fr Introducer

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