STARKEY HEARING TECHNOLOGIES

Basic Information

• Brand Name: STARKEY HEARING TECHNOLOGIES
• Primary DI: 00842318168535
• Version / Model: STARKEY HEARING TECHNOLOGIES TV
• Catalog Number: 43005-001
• Company Name: STARKEY LABORATORIES, INC.
• Labeler DUNS: 055461479
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-27
• Public Version: 1
• Public Version Date: 2018-09-27
• Public Version Status: New
• Public Device Record Key: b8ec6c07-528c-4eef-8545-1cf85adb5f8e

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: 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
OSM	Hearing aid, air conduction with wireless technology	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41243	Television set listening aid	A device used by a person that is hard of hearing to listen to a television (TV) set. It takes the sound output from a TV, either by a direct electrical connection or by means of a microphone placed close to the TV loudspeaker, amplifies the signal which is then fed to the user by means of an earphone or an induction loop in conjunction with an appropriate hearing aid.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842318168535	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity