70105.3824

GUDID 04037691725079

Maquet Cardiopulmonary AG

Extracorporeal membrane oxygenator
Primary Device ID04037691725079
NIH Device Record Keyd152c0bb-53a2-4a03-9ef4-df7964c94cc4
Commercial Distribution Discontinuation2020-02-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberQUADROX-iD Adult, BIOLINE Coating
Catalog Number70105.3824
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
GS104037691725062 [Primary]
GS104037691725079 [Package]
Contains: 04037691725062
Package: [4 Units]
Discontinued: 2020-02-01
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOXYGENATOR, 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

Devices Manufactured by Maquet Cardiopulmonary AG

04037691002583 - NA2024-09-30
04037691349190 - BMU 402024-09-30
04037691349206 - BMU 402024-09-30
04037691349213 - BMU 402024-09-30
04037691349220 - BMU 402024-09-30
04037691349237 - BMU 402024-09-30
04037691349244 - BMU 402024-09-30
04037691456584 - NA2024-09-30 Wall holder for ambulance. Mandatory for ambulance transportation.

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