S5 Shelf with AC Outlet Strip

GUDID 04033817901402

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type
Primary Device ID04033817901402
NIH Device Record Key17f1a655-708d-4600-8757-2c320da9ec2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameS5 Shelf with AC Outlet Strip
Version Model Number5 pos.
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
GS104033817901402 [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 Date2015-10-20

On-Brand Devices [S5 Shelf with AC Outlet Strip]

040338179014025 pos.
040338179013724 pos.
040338179013413 pos.

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