Edwards EVOQUE Valve 9850EV56US

GUDID 00690103219074

Edwards EVOQUE Valve, 56mm

Edwards Lifesciences LLC

Tricuspid transcatheter heart valve bioprosthesis
Primary Device ID00690103219074
NIH Device Record Keya66bc8fc-df0c-4dab-8101-9a61582901b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdwards EVOQUE Valve
Version Model Number9850EV56US
Catalog Number9850EV56US
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 Datetrue
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103219074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPWPercutaneously Delivered Prostheses And Tricuspid Valves

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-11
Device Publish Date2024-10-03

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