GUDID 20763000416069

CUSTOM PACK 11J30R2 10PK SUPP LINE

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
Primary Device ID20763000416069
NIH Device Record Keya9dfb95c-ce87-4df3-8035-420d3d98ff78
Commercial Distribution StatusIn Commercial Distribution
Version Model Number11J30R2
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS100763000416058 [Primary]
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 Units]
In Commercial Distribution
GS120763000416069 [Package]
Contains: 00763000416058
Package: PK [10 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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by MEDTRONIC, INC.

00763000270988 - SimuPlus™2020-08-07 BAND 7700FB26 SIMUPLUS FLEX 26MM US
00763000270995 - SimuPlus™2020-08-07 BAND 7700FB28 SIMUPLUS FLEX 28MM US
00763000271008 - SimuPlus™2020-08-07 BAND 7700FB30 SIMUPLUS FLEX 30MM US
00763000271015 - SimuPlus™2020-08-07 BAND 7700FB32 SIMUPLUS FLEX 32MM US
00763000271022 - SimuPlus™2020-08-07 BAND 7700FB34 SIMUPLUS FLEX 34MM US
00763000271039 - SimuPlus™2020-08-07 BAND 7700FB36 SIMUPLUS FLEX 36MM US
00763000271046 - SimuPlus™2020-08-07 BAND 7700FB38 SIMUPLUS FLEX 38MM US
00763000271053 - SimuPlus™2020-08-07 BAND 7700FB40 SIMUPLUS FLEX 40MM US

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.