Revi™ Wearable Device

Basic Information

• Brand Name: Revi™ Wearable Device
• Primary DI: 07290017912028
• Version / Model: MA-1004-0500
• Company Name: BLUEWIND MEDICAL LTD
• Labeler DUNS: 534159913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 1
• Public Version Date: 2023-09-25
• Public Version Status: New
• Public Device Record Key: e3a57457-5b85-45b7-9cfd-17888178e70e

Device Description

The Revi Wearable Device wirelessly powers the Revi Implant and enables control of stimulation parameters.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QXM	Implanted Tibial Electrical Urinary Continence Device	Gastroenterology, Urology	876.5305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64780	Tibial nerve implantable incontinence-control electrical stimulation system	An assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the sacral plexus via tibial nerve stimulation. It consists of an electrode implanted in the vicinity of the tibial nerve, an external transcutaneous pulse generator attached to the leg, and an external programmer/transmitter that communicates with the pulse generator.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017912028	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN220073	000