Revi™ System Patient Kit

GUDID 07290017912240

Revi System Patient Kit intended for patient use containing device components to support therapy.

BLUEWIND MEDICAL LTD

Tibial nerve implantable incontinence-control electrical stimulation system

• Primary Device ID: 07290017912240
• NIH Device Record Key: 0fd60b39-e8d0-4db4-bab9-67977124d260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revi™ System Patient Kit
• Version Model Number: KA-3000-0001_US_CM
• Company DUNS: 534159913
• Company Name: BLUEWIND MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com
• Phone: 18887152080
• Email: info@bluewindmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017912240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220073

FDA Product Code

• QXM: Implanted Tibial Electrical Urinary Continence Device

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: 2026-02-05
• Device Publish Date: 2026-01-28

On-Brand Devices [Revi™ System Patient Kit]

• 07290017912226: Revi System Patient Kit intended for patient use containing device components to support therapy
• 07290017912240: Revi System Patient Kit intended for patient use containing device components to support therapy