MENIETT®

Basic Information

• Brand Name: MENIETT®
• Primary DI: 00643169576476
• Version / Model: 1010020601LO
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-01
• Public Version: 3
• Public Version Date: 2019-03-04
• Public Version Status: Update
• Public Device Record Key: 652873ff-00c0-49e0-b193-fe2bf78982c1

Device Description

GENERATOR 1010020601LO MENIETT LOANER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETY	TESTER, AUDITORY IMPEDANCE	Ear, Nose, Throat	874.1090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169576476	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K991562	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 15 – 35 Degrees Celsius