70104.9584

GUDID 04037691720791

CARDIOHELP Holder for mast

Maquet Cardiopulmonary AG

Medical device rail
Primary Device ID04037691720791
NIH Device Record Keyf2d17407-cb28-40d3-bc2d-a3ee47a389da
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCARDIOHELP Holder for mast HKH 9102-M
Catalog Number70104.9584
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
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104037691720791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTQCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-12-11
Device Publish Date2016-02-29

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 - NA2024-12-11CARDIOHELP 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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