AFFLELOU

GUDID 00840388210529

Starkey Laboratories, Inc.

Tinnitus masking application software

• Primary Device ID: 00840388210529
• NIH Device Record Key: 7a179817-c8b3-4ada-8fcb-b103e90dce9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFLELOU
• Version Model Number: Incognito OM AI 16 mRIC
• Company DUNS: 055461479
• Company Name: Starkey Laboratories, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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
• 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
• 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
• 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	00840388210529 [Primary]

FDA Product Code

• KLW: Masker, tinnitus

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: 2025-09-04
• Device Publish Date: 2025-08-27

On-Brand Devices [AFFLELOU]

• 00840388209448: Incognito GS 12 RIC 312
• 00840388203019: AFFLELOU INCOGNITO SIGNATURE 12 CIC NW
• 00840388203002: AFFLELOU INCOGNITO SIGNATURE 16 CIC NW
• 00840388202999: AFFLELOU INCOGNITO SIGNATURE 24 CIC NW
• 00840388202975: AFFLELOU INCOGNITO SIGNATURE 12 CIC R NW
• 00840388202968: AFFLELOU INCOGNITO SIGNATURE 16 CIC R NW
• 00840388202951: AFFLELOU INCOGNITO SIGNATURE 24 CIC R NW
• 00840388211588: Incognito OM AI CROS RIC RT
• 00840388211090: Incognito OM AI 16 CIC
• 00840388211083: Incognito OM AI 24 CIC
• 00840388210529: Incognito OM AI 16 mRIC
• 00840388210512: Incognito OM AI 24 mRIC
• 00840388207383: Incognito Edge AI 24 RIC RT (TIER DEMO)
• 00840388207154: INCOGNITO OM AI 16 RIC RT
• 00840388206881: Incognito OM AI 24 RIC RT