FDA.reportPublic FDA data

Revi™ System Patient Kit

Primary DI
07290017912226
Brand
Revi™ System Patient Kit
Company
BLUEWIND MEDICAL LTD
Model
KA-9000-0001_US_CM
Device description
Revi System Patient Kit intended for patient use containing device components to support therapy.
Published
2023-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QXMImplanted Tibial Electrical Urinary Continence Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXMImplanted Tibial Electrical Urinary Continence DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220073000Revi SystemBluewind Medical , Ltd.2023-08-16QXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017912226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017912226072900179122267290017912226

GMDN Terms#

Term, Definition table
TermDefinition
Tibial nerve implantable incontinence-control electrical stimulation systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18887152080info@bluewindmedical.com

Regulatory Flags#

DUNS number
534159913
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017912042Revi™ Wearable DeviceMA-3000-13002026-01-28
07290017912097Revi™ Implant MA-1007-16002026-01-28
07290017912240Revi™ System Patient KitKA-3000-0001_US_CM2026-01-28
07290017912387Revi™ System Physician KitKA-3000-0002_US_CM2026-01-28
07290017912011Revi™ ImplantMA-1007-0600_US_CM2023-09-15
07290017912028Revi™ Wearable DeviceMA-1004-05002023-09-15
07290017912035Revi™ Clinician ProgrammerDV-9500-0001_US_CM2023-09-15
07290017912332Revi™ System Physician KitKA-9000-0002_US_CM2023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017912042Revi™ Wearable DeviceBLUEWIND MEDICAL LTDQXM2026-01-28
07290017912097Revi™ Implant BLUEWIND MEDICAL LTDQXM2026-01-28
07290017912240Revi™ System Patient KitBLUEWIND MEDICAL LTDQXM2026-01-28
07290017912387Revi™ System Physician KitBLUEWIND MEDICAL LTDQXM2026-01-28
07290017912011Revi™ ImplantBLUEWIND MEDICAL LTDQXM2023-09-15
07290017912028Revi™ Wearable DeviceBLUEWIND MEDICAL LTDQXM2023-09-15
07290017912035Revi™ Clinician ProgrammerBLUEWIND MEDICAL LTDQXM2023-09-15
07290017912332Revi™ System Physician KitBLUEWIND MEDICAL LTDQXM2023-09-15