S5 Mast Roller Pump

GUDID 04033817900917

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 ID04033817900917
NIH Device Record Key2cacbef5-6d2c-425c-a527-bcf0fe0e3a75
Commercial Distribution StatusIn Commercial Distribution
Brand NameS5 Mast Roller Pump
Version Model NumberColor Coding Set
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 Numberfalse
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
GS104033817900917 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-05-07
Device Publish Date2015-10-16

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
04033817900917Color Coding Set
04033817900825Control Panel for 2 MRP85
04033817900818Control Panel for 1 MRP
04033817900481MRP 85
04033817900474MRP 150
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