Virtual Kit Number

GUDID 04033817901693

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type
Primary Device ID04033817901693
NIH Device Record Keyb3aa2f18-7774-4a81-a390-0c4d3151143d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVirtual Kit Number
Version Model NumberS5 LUFTBLASENÜBWERWACHUNG APC
Company DUNS343225272
Company NameLivaNova Deutschland GmbH
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104033817901693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTQCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-31
Device Publish Date2024-07-23

On-Brand Devices [Virtual Kit Number]

04033817903000B-Capta VENOUS ONLY
04033817901617B-Capta FULL SYSTEM
04033817901693S5 LUFTBLASENÜBWERWACHUNG APC

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