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
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
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.
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

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50690103219611 - ForeSight IQ2025-07-21 ForeSight Sensor Large IQ
50690103205768 - Acumen IQ Sensor with Fluid Meter2025-07-18 ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER 5-PACK
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00690103205817 - Acumen IQ Fluid Meter2025-07-18 Acumen IQ Fluid Meter
50690103205829 - ACUMEN IQ2025-07-18 Acumen IQ Fluid Meter

Trademark Results [COMMANDER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COMMANDER
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2024-04-24
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2024-04-24
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2024-02-29
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2024-02-29
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Emerson, Ernest
2024-02-21
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2024-02-21
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2024-02-19
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2023-12-05
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REV Recreation Group, Inc.
2023-05-31
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2021-09-03
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2021-07-31
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90769573 not registered Live/Pending
Arrowds, LLC
2021-06-11

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