COMMANDER 9750CM29A

GUDID 00690103217001

Commander DS with SAPIEN 3 Ultra Loader

Edwards Lifesciences LLC

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00690103217001
• NIH Device Record Key: 64c1dae5-abf8-4a3b-af85-817c35dcbc0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMMANDER
• Version Model Number: 9750CM29
• Catalog Number: 9750CM29A
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103217001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140031

FDA Product Code

• NPU: Prosthesis, Mitral Valve, Percutaneously Delivered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

Devices Manufactured by Edwards Lifesciences LLC

• 00690103217124 - HemoSphere Vita: 2024-03-05 PRESSURE CONTROLLER KIT
• 00690103218848 - HemoSphere Vita: 2024-03-05 VitaWave Module
• 00690103218855 - HemoSphere Vita: 2024-03-05 HemoSphere Vita Monitor
• 00690103218862 - HemoSphere Vita: 2024-03-05 Vita Technology Module
• 50690103218898 - VitaWave: 2024-02-28 VitaWave Finger Cuff Adult
• 00690103217483 - EVOQUE: 2024-02-15 Edwards EVOQUE Stabilizer Plate
• 00690103217490 - EVOQUE: 2024-02-15 Edwards EVOQUE Loading System
• 00690103217506 - EVOQUE: 2024-02-15 Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators)