Bubble Detector

GUDID 04033817900580

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type
Primary Device ID04033817900580
NIH Device Record Keye700e699-4d52-4671-80d7-a81be8efb7f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBubble Detector
Version Model NumberSensor 1/2"
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
GS104033817900580 [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 [Bubble Detector]

04033817902591Sensor Module
04033817900665Sensor Module
04033817900603Sensor 3/16"
04033817900597Sensor 3/8"
04033817900580Sensor 1/2"
04033817900573Sensor 1/4"

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