S5 Roller Pump 150

GUDID 04033817900245

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type
Primary Device ID04033817900245
NIH Device Record Key812a320d-1e7b-443a-9a09-ca774aa9a372
Commercial Distribution StatusIn Commercial Distribution
Brand NameS5 Roller Pump 150
Version Model NumberInserts 1/8" x 1/16"
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
GS104033817900245 [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 Roller Pump 150]

04033817902713RP 150
04033817900382RP 150
04033817900375Inserts Cardioplegia 8:1
04033817900368Inserts Cardioplegia 4:1
04033817900351Inserts Cardioplegia 2:1
04033817900344Inserts Cardioplegia 2:1
04033817900337Inserts Cardioplegia 1:1
04033817900320Inserts Cardioplegia 1:1
04033817900313Inserts 1/2" x 3/32"
04033817900306Inserts 1/2" x 1/16"
04033817900290Inserts 3/8" x 3/32"
04033817900283Inserts 3/8" x 1/16"
04033817900276Inserts 1/4" x 3/32"
04033817900269Inserts 1/4" x 1/16"
04033817900252Inserts 3/16" x 1/16"
04033817900245Inserts 1/8" x 1/16"

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