DEVICE: Meniett® (00721902935220)
Device Identifier (DI) Information
Meniett®
1010020601
Not in Commercial Distribution
MEDTRONIC XOMED, INC.
1010020601
Not in Commercial Distribution
MEDTRONIC XOMED, INC.
DEVICE 1010020601 MENIETT GENERATOR
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -40 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4776318b-9581-4922-bd2f-618232408ddc
May 22, 2024
4
September 29, 2016
May 22, 2024
4
September 29, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com