TandemLife

GUDID 00814112020470

Extracorporeal membrane oxygenator

Primary Device ID	00814112020470
NIH Device Record Key	ef33bdae-275d-49ee-9d54-47fd6fe0e3db
Commercial Distribution Status	In Commercial Distribution
Brand Name	TandemLife
Version Model Number	5740-0000
Company DUNS	948683941
Company Name	CARDIACASSIST, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00814112020470 [Primary]

DTZ	Oxygenator, Cardiopulmonary Bypass

Steralize Prior To Use	false
Device Is Sterile	true

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

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