701022009

GUDID 04037691009025

Maquet Cardiopulmonary AG

Desk mount
Primary Device ID04037691009025
NIH Device Record Key325d752f-da71-47b2-a932-f3dd2abf348d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHolder for Oxygenator
Catalog Number701022009
Company DUNS316153865
Company NameMaquet Cardiopulmonary AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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+4972229320
Emailinfo.cp@maquet.com
Phone+4972229320
Emailinfo.cp@maquet.com
Phone+4972229320
Emailinfo.cp@maquet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104037691009025 [Primary]

FDA Product Code

KRIACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-12-06
Device Publish Date2016-02-12

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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