Neutral

Basic Information

• Brand Name: Neutral
• Primary DI: 05714464012909
• Version / Model: 228206
• Company Name: Sbo Hearing A/S
• Labeler DUNS: 306018410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-06
• Public Version: 2
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: c48e8de7-daf9-444f-ae48-3041173e5baf

Device Description

RemoteFit 3.3.0 Android

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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
KLW	Masker, tinnitus	Ear, Nose, Throat	874.3400	2
OSM	Hearing aid, air conduction with wireless technology	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57885	Hearing aid/implant system remote control	A battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05714464012909	GS1

Customer Contacts

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