TandemLife

GUDID 00814112020500

TandemLife Priming Tray Accessory Kit

CARDIACASSIST, INC.

Mechanical infusion pump administration set
Primary Device ID00814112020500
NIH Device Record Key133fc0b2-b09a-4613-ae9f-6f1a0c7dc77a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandemLife
Version Model Number5180-0001
Company DUNS948683941
Company NameCARDIACASSIST, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020500 [Primary]

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 Number3
Public Version Date2018-10-03
Device Publish Date2017-06-07

On-Brand Devices [TandemLife]

00814112020524TandemHeart blood pump,TandemLung Oxygenator,15 Fr Arterial,24 Fr Venous Cannnula and accessorie
00814112020517TandemHeart blood pump,TandemLung Oxygenator,17 Fr Arterial 24 Fr Venous Cannula, and accessorie
00814112020500TandemLife Priming Tray Accessory Kit
00814112020494TandemLife Priming Tray Kit: TandemHeart Blood Pump with TandemLung Oxygenator
00814112020470TandemLife blood pump kit with oxygenator and accessories

Trademark Results [TandemLife]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TANDEMLIFE
TANDEMLIFE
86417701 5064789 Live/Registered
CardiacAssist, Inc.
2014-10-08

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