Bio-Pump+™

GUDID 00643169630581

PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump
Primary Device ID00643169630581
NIH Device Record Key6f824d9a-283f-44ff-9765-031ce5a7f2ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-Pump+™
Version Model NumberCBBPX-80
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 Diameter9.53 Millimeter
Lumen/Inner Diameter9.53 Millimeter
Lumen/Inner Diameter9.53 Millimeter
Lumen/Inner Diameter9.53 Millimeter
Lumen/Inner Diameter9.53 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169630581 [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+™]

20643169794799PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK
00643169630581PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L

Trademark Results [Bio-Pump+]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIO-PUMP+
BIO-PUMP+
75594548 2532504 Dead/Cancelled
Medtronic, Inc.
1998-11-24

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