TandemLung

GUDID 00814112020241

TandemLung Oxygenator Kit with accessories

CARDIACASSIST, INC.

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator
Primary Device ID00814112020241
NIH Device Record Key2d3b6ec3-2a0f-4e9c-8fc6-bb24eb78f51b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandemLung
Version Model Number5160-0000
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 Batchfalse
Serial Numbertrue
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

Phone+18003737421
Emailgjohnson@tandemlife.com
Phone+18003737421
Emailgjohnson@tandemlife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOxygenator, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-22
Device Publish Date2016-04-06

On-Brand Devices [TandemLung]

00814112020432TandemHeart blood pump kit with 31 Fr V-V cannula, TandemLung oxygenator, and accessories
00814112020425TandemHeart blood pump kit with 29 Fr V-V cannula, TandemLung oxygenator, and accessories
00814112020241TandemLung Oxygenator Kit with accessories

Trademark Results [TandemLung]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TANDEMLUNG
TANDEMLUNG
86346986 5050270 Live/Registered
CardiacAssist, Inc.
2014-07-24
TANDEMLUNG
TANDEMLUNG
85965234 not registered Dead/Abandoned
CardiacAssist, Inc.
2013-06-20

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