TandemLung LifeSPARC

GUDID 00814112020760

LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous cannula and accessories

CARDIACASSIST, INC.

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump
Primary Device ID00814112020760
NIH Device Record Key6212d8c0-1d0c-455e-9bc9-07b1d6b0ebaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandemLung LifeSPARC
Version Model Number5830-3118
Company DUNS948683941
Company NameCARDIACASSIST, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com
Phone18003737421
Emailtl.regulatory@livanova.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020760 [Primary]

FDA Product Code

KRIAccessory Equipment, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-29

On-Brand Devices [TandemLung LifeSPARC]

00814112020777LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous Rapid Deployment cannul
00814112020760LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous cannula and accessories
00814112020753LifeSPARC Blood Pump, TandemLung Oxygenator, 29 Fr ProtekDuo Veno-Venous cannula and accessories

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