STARKEY HEARING TECHNOLOGIES 43005-001

GUDID 00842318168535

STARKEY LABORATORIES, INC.

Television set listening aid

• Primary Device ID: 00842318168535
• NIH Device Record Key: b8ec6c07-528c-4eef-8545-1cf85adb5f8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARKEY HEARING TECHNOLOGIES
• Version Model Number: STARKEY HEARING TECHNOLOGIES TV
• Catalog Number: 43005-001
• Company DUNS: 055461479
• Company Name: STARKEY LABORATORIES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842318168535 [Primary]

FDA Product Code

• OSM: Hearing aid, air conduction with wireless technology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-27
• Device Publish Date: 2018-08-27

On-Brand Devices [STARKEY HEARING TECHNOLOGIES]

• 00842318168542: STARKEY HEARING TECHNOLOGIES TV
• 00842318168535: STARKEY HEARING TECHNOLOGIES TV
• 00842318168528: STARKEY HEARING TECHNOLOGIES TV
• 00842318168511: STARKEY HEARING TECHNOLOGIES TV
• 00842318168504: STARKEY HEARING TECHNOLOGIES REMOTE MICROPHONE +
• 00842318168498: STARKEY HEARING TECHNOLOGIES REMOTE MICROPHONE +
• 00842318168481: STARKEY HEARING TECHNOLOGIES REMOTE
• 00842318168474: STARKEY HEARING TECHNOLOGIES REMOTE
• 00842318168467: STARKEY HEARING TECHNOLOGIES REMOTE
• 00842318168450: STARKEY HEARING TECHNOLOGIES REMOTE
• 00842318174703: STARKEY HEARING TECHNOLOGIES CHARGER
• 00842318174574: STARKEY HEARING TECHNOLOGIES CHARGER
• 00842318174499: STARKEY HEARING TECHNOLOGIES CHARGER
• 00842318174413: STARKEY HEARING TECHNOLOGIES CHARGER
• 00842318174338: STARKEY HEARING TECHNOLOGIES CHARGER
• 00842318173829: STARKEY HEARING TECHNOLOGIES MINI REMOTE MICROPHON
• 00842318173607: STARKEY HEARING TECHNOLOGIES MINI REMOTE MICROPHON
• 00842318173522: STARKEY HEARING TECHNOLOGIES MINI REMOTE MICROPHON
• 00842318173447: STARKEY HEARING TECHNOLOGIES MINI REMOTE MICROPHON
• 00842318176561: STARKEY HEARING TECHNOLOGIES TABLE MICROPHONE
• 00842318176554: STARKEY HEARING TECHNOLOGIES TABLE MICROPHONE
• 00842318176547: STARKEY HEARING TECHNOLOGIES SURFLINK ADAPTER