GUDID 20763000402673

CUSTOM PACK 11J08R1 5PK ADULT SUPP PACK

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
Primary Device ID20763000402673
NIH Device Record Key4a79668b-c379-4a88-bef8-31f01459328d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number11J08R1
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS100763000402662 [Primary]
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
Package: PK [5 Units]
In Commercial Distribution
GS120763000402673 [Package]
Contains: 00763000402662
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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

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20763000402338 - NA2020-06-23 CUSTOM PACK 11C06R 50PK STERILE TIES
00763000402570 - NA2020-06-23 CUSTOM PACK CB6Y39R8 L SUPPORT
20763000402673 - NA2020-06-23CUSTOM PACK 11J08R1 5PK ADULT SUPP PACK
20763000402673 - NA2020-06-23 CUSTOM PACK 11J08R1 5PK ADULT SUPP PACK
00763000118280 - N/A2020-06-08 MAPPING SYSTEM CIT200 US
00763000301323 - Affinity™ CP2020-06-08 ADAPTER AP40AST AFFINITY CP WW 31L
00763000301330 - Affinity™2020-06-08 HANDCRANK HC150A PLX 31L

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