BIO-PUMP®

GUDID 20613994406938

PUMP 95171 BIOPUMP BP50 STER 3L 4PK

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump
Primary Device ID20613994406938
NIH Device Record Keyd7be8d9d-84ce-4192-bd8e-e91ad1fa5ea5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIO-PUMP®
Version Model Number95171
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994406934 [Primary]
GS120613994406938 [Package]
Contains: 00613994406934
Package: PK [4 Units]
In Commercial Distribution

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 Number3
Public Version Date2018-07-06
Device Publish Date2014-09-25

On-Brand Devices [BIO-PUMP®]

00613994413031PUMP CBBP50 BIOPUMP 6HR CB PED ST 3L
20613994406938PUMP 95171 BIOPUMP BP50 STER 3L 4PK

Trademark Results [BIO-PUMP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIO-PUMP
BIO-PUMP
76418171 2731695 Live/Registered
Zefon International, Inc.
2002-06-10
BIO-PUMP
BIO-PUMP
74455329 1854560 Dead/Cancelled
Medtronic Bio-Medicus, Inc.
1993-11-08
BIO-PUMP
BIO-PUMP
73074863 1045349 Live/Registered
BIO-MEDICUS, INC.
1976-01-21

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