AccessGUDID - DEVICE: Meniett® (00721902935220)

GUDID

Device Identifier (DI) Information

Brand Name: Meniett®
Version or Model: 1010020601
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 00721902935220
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: DEVICE 1010020601 MENIETT GENERATOR

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?
61904	Endolymph evacuator	A portable, hand-held, mains electricity (AC-powered) device, that includes internal rechargeable batteries, intended to produce and deliver low frequency and amplitude pressure pulses to the inner ear to reduce endolymph volume as a treatment for Meniere's disease. It consists of a main unit with connected tubing and an ear cuff for insertion into the external ear canal. The pressure pulses are generated by the ear cuff and transmitted through the ear canal to the middle ear, via a previously implanted tympanostomy tube, to induce fluid drainage from the labyrinth to other ear cavities (e.g., mastoid), where resorption occurs. The device is intended to be used at home by the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETY	TESTER, AUDITORY IMPEDANCE

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
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4776318b-9581-4922-bd2f-618232408ddc
Public Version Date: May 22, 2024
Public Version Number: 4
DI Record Publish Date: September 29, 2016