FDA.reportPublic FDA data

MENIETT®

Primary DI
00643169576476
Brand
MENIETT®
Company
MEDTRONIC XOMED, INC.
Model
1010020601LO
Device description
GENERATOR 1010020601LO MENIETT LOANER
Published
2016-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETYTESTER, AUDITORY IMPEDANCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991562000PASCAL MEDICAL AB MENIETT 20Pascal Medical AB1999-12-28ETY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169576476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169576476006431695764766431695764760643169576476

GMDN Terms#

Term, Definition table
TermDefinition
Endolymph evacuatorA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Serial number
true

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