70105.4265

GUDID 04037691740331

Maquet Cardiopulmonary AG

Cardiotomy reservoir
Primary Device ID04037691740331
NIH Device Record Keyaa732453-ae29-4fab-970a-15434830d339
Commercial Distribution Discontinuation2020-02-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberVenous Reservoir Bag 800 ml
Catalog Number70105.4265
Company DUNS316153865
Company NameMaquet Cardiopulmonary AG
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49072229320
Emailinfo.cp@maquet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104037691740331 [Package]
Contains: 04037691740348
Package: [10 Units]
Discontinued: 2020-02-01
Not in Commercial Distribution
GS104037691740348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-02-03
Device Publish Date2015-10-24

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04037691576640 - Quadrox-iD 2022-12-13
04037691588285 - HLS Set2022-12-13
04037691741130 - NA2022-12-08
04037691741543 - NA2022-12-08
04037691773513 - NA2022-12-08
04037691009025 - NA2022-12-06

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