PulseSelect™

GUDID 00763000617783

FOOTSWITCH PSFS100 PFA US

MEDTRONIC, INC.

Foot-switch, electrical

• Primary Device ID: 00763000617783
• NIH Device Record Key: 43177518-7624-43c5-8d5e-ca1d311f7362
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PulseSelect™
• Version Model Number: PSFS100
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000617783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230017

FDA Product Code

• QZI: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-19
• Device Publish Date: 2024-02-10

On-Brand Devices [PulseSelect™]

• 00763000617752: REMOTE CONTROL PSRC101 PFA 25FT US
• 00763000617745: REMOTE CONTROL PSRC100 PFA 10 FT US
• 00763000617530: GENERATOR PSG100 PULSESELECT US
• 00763000617554: CATHETER PSCC100 PULSESELECT US 25MM
• 00763000617783: FOOTSWITCH PSFS100 PFA US
• 00763000617592: CABLE PSCIC101 CATHETER PFA US
• 00763000617578: CABLE PSEGM100 EGM US
• 00763000897215: GENERATOR PSG100 PULSESELECT LOANER US