DEVICE: Meniett® (00721902935220)

Device Identifier (DI) Information

Meniett®
1010020601
Not in Commercial Distribution

MEDTRONIC XOMED, INC.
00721902935220
GS1
December 06, 2023
1
835465063 *Terms of Use
DEVICE 1010020601 MENIETT GENERATOR
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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
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FDA Product Code

[?]
Product Code Product Code Name
ETY TESTER, AUDITORY IMPEDANCE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4776318b-9581-4922-bd2f-618232408ddc
May 22, 2024
4
September 29, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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