EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS26A

GUDID 00690103193954

Edwards Lifesciences LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework
Primary Device ID00690103193954
NIH Device Record Key3483ff53-c283-48f3-bd72-aae47238366b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDWARDS COMMANDER DELIVERY SYSTEM
Version Model Number9600LDS26
Catalog Number9600LDS26A
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
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 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
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Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103193954 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-07-05

On-Brand Devices [EDWARDS COMMANDER DELIVERY SYSTEM]

006901031939619600LDS29
006901031939549600LDS26
006901031939479600LDS
006901031939309600LDS20

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