Meniett ® Pulse Generator MT-GEN

GUDID 05708265005062

A manual device intended to reduce the symptoms associated with negative air pressure in the middle ear by increasing air pressure in the Eustachian t

Lina Medical ApS

Middle ear decompressor, positive pressure

• Primary Device ID: 05708265005062
• NIH Device Record Key: 8493f99a-b759-4843-ab03-7ccd14b2948c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meniett ® Pulse Generator
• Version Model Number: MT-GEN
• Catalog Number: MT-GEN
• Company DUNS: 305088619
• Company Name: Lina Medical ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +48612222140
• Email: info.poland@lina-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708265005062 [Primary]

FDA Product Code

• ETY: Tester, Auditory Impedance

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-14

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