GUDID 20763000425832

CUSTOM PACK HY11L70R 4PK CP 2013

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 ID20763000425832
NIH Device Record Keyb4caa3d0-23b4-4e2c-b7a5-c37b3663f50d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHY11L70R
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 Producttrue
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 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS100763000425821 [Primary]
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 Units]
In Commercial Distribution
GS120763000425832 [Package]
Contains: 00763000425821
Package: PK [4 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 Date2020-09-14
Device Publish Date2020-09-06

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00763000060015 - Evera MRI™ S DR SureScan™2020-09-14 ICD-DR DDMC3D1 EVERA MRI S US DF1
00763000060060 - Visia AF MRI™ S VR SureScan™2020-09-14 ICD-VR DVFC3D4 VISIA AF MRI S US DF4
00763000060091 - Compia MRI™ CRT-D SureScan™2020-09-14 CRTD DTMC1D1 COMPIA MRI US DF1
00763000060107 - Visia AF MRI™ S VR SureScan™2020-09-14 ICD-VR DVFC3D1 VISIA AF MRI S US DF1
00763000343293 - INTERSTIM® Twist-Lock Cable2020-09-14 CABLE 357625 ISTM TEST TWST LCK GLBL MDR

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