Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX26A

GUDID 00690103201338

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable
Primary Device ID00690103201338
NIH Device Record Key7425b7bd-8e86-4f94-95f6-053ff9c8dd36
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdwards SAPIEN 3 Ultra Transcatheter Heart Valve
Version Model Number9750TFX26
Catalog Number9750TFX26A
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
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
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

Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius degree.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103201338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPUProsthesis, Mitral Valve, Percutaneously Delivered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-27
Device Publish Date2019-01-08

On-Brand Devices [Edwards SAPIEN 3 Ultra Transcatheter Heart Valve]

00690103201338Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
00690103201321Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
00690103201314Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

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