KONECT RESILIA 11060A29

GUDID 00690103201406

aortic valved conduit

Edwards Lifesciences LLC

Aortic heart valve bioprosthesis/synthetic polymer aorta graft
Primary Device ID00690103201406
NIH Device Record Keyb4b64917-6d07-4338-b489-2c3ad0f37e7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKONECT RESILIA
Version Model Number11060A
Catalog Number11060A29
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103201406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRHeart-Valve, Non-Allograft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-27
Device Publish Date2020-07-17

On-Brand Devices [KONECT RESILIA ]

00690103201406aortic valved conduit
00690103201390aortic valved conduit
00690103201383aortic valved conduit
00690103201376aortic valved conduit
00690103201369aortic valved conduit
00690103193855aortic valved conduit

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