Bio-Pump+™

GUDID 20643169794799

PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump
Primary Device ID20643169794799
NIH Device Record Keya1cc550e-52cb-468f-b533-d398d605f8ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-Pump+™
Version Model Number95201
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

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

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169794795 [Primary]
GS120643169794799 [Package]
Contains: 00643169794795
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 Date2017-01-22

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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