70100.4980

GUDID 04037691141978

Maquet Cardiopulmonary AG

Suction system catheter, general-purpose
Primary Device ID04037691141978
NIH Device Record Keyd437b063-592f-4a45-bc56-d6cd84045942
Commercial Distribution Discontinuation2020-01-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberRigid sucker
Catalog Number70100.4980
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4907222932
Emailinfo.cp@maquet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104037691083230 [Primary]
GS104037691141978 [Package]
Contains: 04037691083230
Package: [10 Units]
Discontinued: 2020-01-31
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-31
Device Publish Date2015-10-24

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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