Bio-Pump™

GUDID 00643169630604

PUMP CBBP50 BIOPUMP 6HR CB PED ST 3L

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump
Primary Device ID00643169630604
NIH Device Record Key0ca9f717-a143-46ba-bab3-1e6911e47612
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-Pump™
Version Model NumberCBBP50
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 Kitfalse
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

Device Dimensions

Lumen/Inner Diameter6.35 Millimeter
Lumen/Inner Diameter6.35 Millimeter
Lumen/Inner Diameter6.35 Millimeter
Lumen/Inner Diameter6.35 Millimeter
Lumen/Inner Diameter6.35 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device
Storage Environment TemperatureBetween -40 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169630604 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-01-03

On-Brand Devices [Bio-Pump™]

20643169794775PUMP 95171 BIOPUMP BP50 STER 3L 4PK
00643169630604PUMP CBBP50 BIOPUMP 6HR CB PED ST 3L

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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