SOUNDGEAR

GUDID 00840388201596

STARKEY LABORATORIES, INC.

Noninvasive device battery charger

• Primary Device ID: 00840388201596
• NIH Device Record Key: 6c0cd75a-6d1a-4ea4-989a-3cf9d05a516c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOUNDGEAR
• Version Model Number: SoundGear Premium Charger 2.0 (mRIC R)
• 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 Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840388201596 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air-Conduction with Wireless Technology, Prescription

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: 2025-07-03
• Device Publish Date: 2025-06-25

On-Brand Devices [SOUNDGEAR]

• 00840388208816: SOUNDGEAR AMP IIC NW
• 00840388208809: SOUNDGEAR AMP CIC NW
• 00840388208793: SoundGear Remote Control 2.0
• 00840388208786: SoundGear Table Microphone
• 00840388208779: SoundGear Remote Microphone
• 00840388208762: SoundGear TV Streamer
• 00840388208595: Soundgear 2.4 Charger (1 NA Plug)
• 00840388202647: AMP ITC R
• 00840388202616: SOUNDGEAR AMP 24 MRIC R
• 00840388202234: SoundGear Premium Custom Charger 2.0
• 00840388201954: SoundGear Premium Charger 2.0 (RIC RT)
• 00840388201596: SoundGear Premium Charger 2.0 (mRIC R)