ROTAFLOW 70104.7554

GUDID 04037691530871

BEQ-RF-32-USA#RotaFlow Centrifugal Pump with BIOLINE Coating

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump
Primary Device ID04037691530871
NIH Device Record Keya12f997c-5851-41e2-b2c4-c5ba2c49c468
Commercial Distribution StatusIn Commercial Distribution
Brand NameROTAFLOW
Version Model NumberCentrifugal Pump, BIOLINE
Catalog Number70104.7554
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 Producttrue
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
GS104037691530864 [Primary]
GS104037691530864 [Primary]
GS104037691530864 [Primary]
GS104037691530871 [Package]
Contains: 04037691530864
Package: [10 Units]
In Commercial Distribution
GS104037691530871 [Package]
Contains: 04037691530864
Package: [10 Units]
In Commercial Distribution
GS104037691530871 [Package]
Contains: 04037691530864
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KFMPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
KFMPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.