TandemLung

GUDID 00814112020432

TandemHeart blood pump kit with 31 Fr V-V cannula, TandemLung oxygenator, and accessories

CARDIACASSIST, INC.

Mobile extracorporeal gas exchange system catheter kit Mobile extracorporeal gas exchange system catheter kit Mobile extracorporeal gas exchange system catheter kit Mobile extracorporeal gas exchange system catheter kit Mobile extracorporeal gas exchange system catheter kit
Primary Device ID00814112020432
NIH Device Record Key5afcb09a-f6a7-4440-b10f-495e836d9f47
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandemLung
Version Model Number5730-3118
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 Kittrue
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

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
GS100814112020432 [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 Number4
Public Version Date2020-01-22
Device Publish Date2016-09-23

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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