GUDID 20763000505756

CUSTOM PACK 11P59R 5PK 3/8S ACCESSARY P

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set
Primary Device ID20763000505756
NIH Device Record Keyf5871025-a2e2-4f46-8eb4-97abc2743f3e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number11P59R
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
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
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS100763000505745 [Primary]
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution
GS120763000505756 [Package]
Contains: 00763000505745
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

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