Heater-Cooler System

GUDID 04033817900511

LivaNova Deutschland GmbH

Cardiopulmonary bypass system heating/cooling unit
Primary Device ID04033817900511
NIH Device Record Key18aa7a3b-bbfe-42a5-9318-237e9a0d994b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeater-Cooler System
Version Model Number3T 208V ~ / 60Hz
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
GS104033817900511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWCController, temperature, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2015-10-14

On-Brand Devices [Heater-Cooler System]

040338179011123T 240V ~ / 60Hz
040338179005283T 120V ~ / 60Hz
040338179005113T 208V ~ / 60Hz

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