Cardiohelp 701020721

GUDID 04037691260730

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system, roller type
Primary Device ID04037691260730
NIH Device Record Key55b4289d-b2ef-491c-a503-8337de5f3d6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiohelp
Version Model NumberMTK 20-554 Medex LogiCal Transducer Holder
Catalog Number701020721
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+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com
Phone+4972229320
Emailinfo.cp@getinge.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104037691260730 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-08
Device Publish Date2021-09-30

On-Brand Devices [Cardiohelp]

04058863084336CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for connecting the CARD
04037691682549Mast adapter D30 H45
04037691320786Mast adapter D33 H45
04037691260730MTK 20-554 Medex LogiCal Transducer Holder

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.