ProtekDuo

GUDID 00814112020456

Four 25 cm Dilators (14 Fr, 18 Fr, 22 Fr, and 26 Fr)

CARDIACASSIST, INC.

Vascular dilator, single-use
Primary Device ID00814112020456
NIH Device Record Key40b8ac49-36af-4264-901f-5db5193e8dc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtekDuo
Version Model Number5100-1426
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

Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com
Phone4129637770
Emailgjohnson@tandemlife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDilator, Vessel, For Percutaneous Catheterization

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 Date2017-05-22

On-Brand Devices [ProtekDuo]

00814112020555TandemHeart Blood Pump Kit with 31 Fr Mini V-V cannula, TandemLung Oxygentor
00814112020548TandemHeart Blood Pump Kit with 31 Fr Mini Veno-Venous Cannula
0081411202053131 Fr x 36 cm Dual Lumen VV Cannula Set
00814112020456Four 25 cm Dilators (14 Fr, 18 Fr, 22 Fr, and 26 Fr)
00814112020418TandemHeart blood pump kit with 31 Fr veno-venous cannula
00814112020401TandemHeart blood pump kit with 29 Fr veno-venous cannula
0081411202031931 Fr x 51 cm Veno-Venous Dual Lumen Cannula with Introducer

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