70106.4103

GUDID 04037691870304

Holding Clamp for Oxygenator QUADROX-i(D)Adult and Small Adult

Maquet Cardiopulmonary AG

Desk mount
Primary Device ID04037691870304
NIH Device Record Key31b401fd-8047-45f9-89ea-3f5cca010817
Commercial Distribution Discontinuation2020-02-29
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHolding Clamp; QUADROX-i(D) Adult
Catalog Number70106.4103
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS104037691870304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTMFilter, blood, cardiopulmonary bypass, arterial line

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-20
Device Publish Date2015-12-15

Devices Manufactured by Maquet Cardiopulmonary AG

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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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