S5 Mast Roller Pump

GUDID 04033817902744

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type
Primary Device ID04033817902744
NIH Device Record Key1e5c2d12-bec3-487c-8594-df6d2082d294
Commercial Distribution StatusIn Commercial Distribution
Brand NameS5 Mast Roller Pump
Version Model NumberControl Panel for 2 MRP85
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104033817902744 [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 Date2021-05-24
Device Publish Date2021-05-14

On-Brand Devices [S5 Mast Roller Pump]

04033817902775S5 Min.I. Control Panel MRP85
04033817902768S5 Min.I. Control Panel MRP150
04033817902744Control Panel for 2 MRP85
04033817902720Control Panel for 1 MRP
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