Flow Measurement

GUDID 04033817902645

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type
Primary Device ID04033817902645
NIH Device Record Key96578375-cd5e-4cbf-ae23-9b9ec7955c4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlow Measurement
Version Model NumberSensor Module
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
GS104033817902645 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-24
Device Publish Date2021-05-14

On-Brand Devices [Flow Measurement]

04033817902645Sensor Module
04033817901532Sensor Sorin 3/8" x 3/32"
04033817901525Sensor Stöckert 1/4" x 1/16"
04033817901518Sensor Stöckert 1/4" x 3/32"
04033817901501Sensor Stöckert 3/8" x 3/32"
04033817900733Sensor Module

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