70106.7840

GUDID 04037692009925

Maquet Cardiopulmonary AG

Extracorporeal membrane oxygenator
Primary Device ID04037692009925
NIH Device Record Key18ef3248-828c-4f6b-8162-c4932b5d3c7c
Commercial Distribution Discontinuation2017-02-16
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberQUADROX-iD Adult, SOFTLINE Coating
Catalog Number70106.7840
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

Total Volume215 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS104037692009925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS

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

04037691075068 - VBT Venous Bubble Trap2023-06-02 Venous Bubble Trap, BIOLINE Coating (BEQ), and sterile. The Venous Bubble Trap VBT 160 is designed to remove gross air in the ve
04037691032528 - NA2023-06-02
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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