Revi™ System Patient Kit

Basic Information

• Brand Name: Revi™ System Patient Kit
• Primary DI: 07290017912226
• Version / Model: KA-9000-0001_US_CM
• 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: bab4d672-3d14-4b2b-96da-1495e469b5fb

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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	07290017912226	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN220073	000