HL 20 701045168

GUDID 04037691457659

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system, roller type
Primary Device ID04037691457659
NIH Device Record Keya2706c70-e465-4c00-8817-374041b78891
Commercial Distribution StatusIn Commercial Distribution
Brand NameHL 20
Version Model NumberComplete Holder 200mm Arm
Catalog Number701045168
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
GS104037691457659 [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 [HL 20 ]

04037691762326Extended Mast System
04037691585598Side guard
04037691457659Complete Holder 200mm Arm
04037691289939CRM 20-117 Cross Mast,4-pump
04037691276717Temperature box holder
04037691261386CRM 20-118 Cross mast, 5-pump
04037691260129VEM 20-119 Vertic Mast short

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