AccessGUDID - DEVICE: Revi™ Clinician Programmer (07290017912035)

GUDID

Device Identifier (DI) Information

Brand Name: Revi™ Clinician Programmer
Version or Model: DV-9500-0001_US_CM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BLUEWIND MEDICAL LTD

Primary DI Number: 07290017912035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 534159913 *Terms of Use

Device Description: The Revi Clinician Programmer is an application that is the Revi system's interface.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QXM	Implanted Tibial Electrical Urinary Continence Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 049940e0-0a9d-4a5d-9466-877cca50b3ea
Public Version Date: August 13, 2024
Public Version Number: 2
DI Record Publish Date: September 15, 2023