COMMANDER 9750CM29A

GUDID 00690103217001

Commander DS with SAPIEN 3 Ultra Loader

Edwards Lifesciences LLC

Catheter/overtube balloon inflator, single-use
Primary Device ID00690103217001
NIH Device Record Key64c1dae5-abf8-4a3b-af85-817c35dcbc0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMMANDER
Version Model Number9750CM29
Catalog Number9750CM29A
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 Batchtrue
Serial Numberfalse
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

Device Dimensions

Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *The delivery system should be stored in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103217001 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-02
Device Publish Date2022-08-25

Devices Manufactured by Edwards Lifesciences LLC

00690103019063 - HEART VALVE HANDLE ACCESSORY2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS
00690103019339 - HEART VALVE ACCESSOR2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
00690103166989 - HEART VALVE ACCESSOR2024-10-28 MITRAL SIZER HANDLE
00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 462024-10-28 RING HANDLE - EXTENDED 4"
00690103186437 - FLEXIBLE HANDLE2024-10-28 FLEXIBLE HANDLE
00690103210132 - MITRIS Handle 1140M2024-10-28 11400M valve handle
00690103217773 - Edwards EVOQUE Loading System2024-10-11 Edwards EVOQUE Loading System

Trademark Results [COMMANDER]

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