Revi™ Implant

GUDID 07290017912011

Implantable, wireless, battery-less neurostimulation component of the Revi Peripheral Nerve Stimulation System

BLUEWIND MEDICAL LTD

Tibial nerve implantable incontinence-control electrical stimulation system
Primary Device ID07290017912011
NIH Device Record Key2acc7d6c-fe2e-4f8c-b92e-3cc643cd1dde
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevi™ Implant
Version Model NumberMA-1007-0600_US_CM
Company DUNS534159913
Company NameBLUEWIND MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com
Phone(888) 715-2080
Emailinfo@bluewindmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017912011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QXMImplanted Tibial Electrical Urinary Continence Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-25
Device Publish Date2023-09-15

Devices Manufactured by BLUEWIND MEDICAL LTD

07290017912011 - Revi™ Implant2023-09-25Implantable, wireless, battery-less neurostimulation component of the Revi Peripheral Nerve Stimulation System
07290017912011 - Revi™ Implant2023-09-25 Implantable, wireless, battery-less neurostimulation component of the Revi Peripheral Nerve Stimulation System
07290017912028 - Revi™ Wearable Device2023-09-25 The Revi Wearable Device wirelessly powers the Revi Implant and enables control of stimulation parameters.
07290017912035 - Revi™ Clinician Programmer2023-09-25 The Revi Clinician Programmer is an application that is the Revi system's interface.
07290017912226 - Revi™ System Patient Kit2023-09-25 Revi System Patient Kit intended for patient use containing device components to support therapy.
07290017912332 - Revi™ System Physician Kit2023-09-25 Revi™ System Physician Kit is intended to provide physicians necessary device system components to support therapy.

Trademark Results [Revi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REVI
REVI
97758165 not registered Live/Pending
BLUEWIND MEDICAL INC.
2023-01-17
REVI
REVI
97146648 not registered Live/Pending
Eatumup Lure Comapny ,INC.
2021-11-29
REVI
REVI
90466883 not registered Live/Pending
Tay's Sales & Distribution LLC
2021-01-14
REVI
REVI
90298583 not registered Live/Pending
ZYRL Co.
2020-11-04
REVI
REVI
90298572 not registered Live/Pending
ZYRL Co.
2020-11-04
REVI
REVI
90278129 not registered Live/Pending
AIGOU BRAND LIMITED
2020-10-26
REVI
REVI
90179100 not registered Live/Pending
Revi LLC
2020-09-14
REVI
REVI
88445211 not registered Live/Pending
AMQ Solutions, LLC
2019-05-24
REVI
REVI
85695586 4424031 Live/Registered
ReviMedia, Inc.
2012-08-05
REVI
REVI
79247712 5823923 Live/Registered
GRUPO GREMVI GALICIA, S.L.
2018-09-11
REVI
REVI
74591734 2057861 Dead/Cancelled
RECREATIONAL ELECTRIC VEHICLES INT. LLC
1994-10-28
REVI
REVI
73808079 1625005 Live/Registered
EATUMUP LURE COMPANY, INC.
1989-06-21

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.