70106.7859

GUDID 04037692009932

Maquet Cardiopulmonary AG

Extracorporeal membrane oxygenator
Primary Device ID04037692009932
NIH Device Record Key20b6622b-d6b4-48f4-8c9c-44107a4cb837
Commercial Distribution Discontinuation2017-02-16
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberQUADROX-iD Adult, BIOLINE Coating
Catalog Number70106.7859
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 Producttrue
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

Total Volume215 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS104037692009932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTMFilter, blood, cardiopulmonary bypass, arterial line

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-22
Device Publish Date2015-12-15

Devices Manufactured by Maquet Cardiopulmonary AG

04037691645148 - NA2024-12-11 CARDIOHELP Emergency Drive Holder for rail
04037691645155 - NA2024-12-11 CARDIOHELP Emergency Drive Holder for mast
04037691720791 - NA2024-12-11 CARDIOHELP Holder for mast
04037691002583 - NA2024-09-30
04037691349190 - BMU 402024-09-30
04037691349206 - BMU 402024-09-30
04037691349213 - BMU 402024-09-30
04037691349220 - BMU 402024-09-30

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