ROTAFLOW 70101.8066

GUDID 04037691000824

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump
Primary Device ID04037691000824
NIH Device Record Key04084b48-367c-4e3d-b5aa-6d3541949c63
Commercial Distribution StatusIn Commercial Distribution
Brand NameROTAFLOW
Version Model NumberCentrifugal Pump, USA
Catalog Number70101.8066
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+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com
Phone+49072229320
Emailinfo.cp@maquet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104037691000824 [Package]
Contains: 04037691123554
Package: [10 Units]
In Commercial Distribution
GS104037691123554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KFMPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-19
Device Publish Date2015-10-30

On-Brand Devices [ROTAFLOW]

04037691650333BO-RF-32-USA#RotaFlow Centrifugal Pump with SOFTLINE Coating
04037691530871BEQ-RF-32-USA#RotaFlow Centrifugal Pump with BIOLINE Coating
04037691000824Centrifugal Pump, USA

Trademark Results [ROTAFLOW]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROTAFLOW
ROTAFLOW
76378435 2668917 Live/Registered
MAQUET CARDIOPULMONARY GMBH
2002-03-04
ROTAFLOW
ROTAFLOW
75310248 not registered Dead/Abandoned
Jostra Medizintechnik AG
1997-06-17

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