MITRIS RESILIA Mitral Valve 11400M33

GUDID 00690103205572

RESILIA Mitral Valve, size 33 mm

Edwards Lifesciences LLC

Mitral heart valve bioprosthesis
Primary Device ID00690103205572
NIH Device Record Key17781a11-0ba2-4770-a474-1f11063bb7ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameMITRIS RESILIA Mitral Valve
Version Model Number11400M
Catalog Number11400M33
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)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com
Phone+1(800)822-9837
Emailtech_support@edwards.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103205572 [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 Date2022-03-31
Device Publish Date2022-03-23

On-Brand Devices [MITRIS RESILIA Mitral Valve]

00690103205572RESILIA Mitral Valve, size 33 mm
00690103205565RESILIA Mitral Valve, size 31 mm
00690103205558RESILIA Mitral Valve, size 29 mm
00690103205541RESILIA Mitral Valve, size 27 mm
00690103205534RESILIA Mitral Valve, size 25 mm

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