Meniett ® Pulse Generator- LOANER

Basic Information

• Brand Name: Meniett ® Pulse Generator- LOANER
• Primary DI: 05708265010059
• Version / Model: MT-GEN-LO
• Catalog Number: MT-GEN-LO
• Company Name: Lina Medical ApS
• Labeler DUNS: 305088619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-30
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 6dd4276a-db16-4775-874e-b75e8601967e

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: Yes
• 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
47542	Middle ear decompressor, positive pressure	A manual device intended to reduce the symptoms associated with negative air pressure in the middle ear by increasing air pressure in the Eustachian tube, to counter/prevent certain physical states or thick fluid accumulation behind the eardrum. It typically consists of a manually-operated deflator/inflator (e.g., balloon) connected to an applicator (e.g., nosepiece, mouthpiece, face mask). This is a reusable device typically used in the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708265010059	GS1

Customer Contacts

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