STARKEY

GUDID 00840388203781

STARKEY LABORATORIES, INC.

Air-conduction hearing aid, receiver-in-canal

• Primary Device ID: 00840388203781
• NIH Device Record Key: ad3718fd-82b8-4dd8-a1e9-097169f8b3e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARKEY
• Version Model Number: STARKEY EDGE AI 16 MRIC R
• 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
• 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	00840388203781 [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: 2024-12-09
• Device Publish Date: 2024-11-29

On-Brand Devices [STARKEY]

• 00842318168245: STARKEY PICASSO 1000 IIC
• 00842318168238: STARKEY PICASSO 1200 IIC
• 00842318168221: STARKEY PICASSO 1600 IIC
• 00842318168214: STARKEY PICASSO 2000 IIC
• 00842318168207: STARKEY PICASSO 2400 IIC
• 00842318167996: STARKEY PICASSO I1000 IIC
• 00842318167989: STARKEY PICASSO I1200 IIC
• 00842318167972: STARKEY PICASSO I1600 IIC
• 00842318167965: STARKEY PICASSO I2000 IIC
• 00842318167958: STARKEY PICASSO I2400 IIC
• 00842318167149: STARKEY PICASSO 1000 ITE
• 00842318167132: STARKEY PICASSO 1200 ITE
• 00842318167125: STARKEY PICASSO 1600 ITE
• 00842318167118: STARKEY PICASSO 2000 ITE
• 00842318167101: STARKEY PICASSO 2400 ITE
• 00842318167095: STARKEY PICASSO 1000 HALF SHELL
• 00842318167088: STARKEY PICASSO 1200 HALF SHELL
• 00842318167071: STARKEY PICASSO 1600 HALF SHELL
• 00842318167064: STARKEY PICASSO 2000 HALF SHELL
• 00842318167057: STARKEY PICASSO 2400 HALF SHELL
• 00842318167040: STARKEY PICASSO 1000 ITC
• 00842318167033: STARKEY PICASSO 1200 ITC
• 00842318167026: STARKEY PICASSO 1600 ITC
• 00842318167019: STARKEY PICASSO 2000 ITC
• 00842318167002: STARKEY PICASSO 2400 ITC
• 00842318166999: STARKEY PICASSO 1000 CIC
• 00842318166982: STARKEY PICASSO 1200 CIC
• 00842318166975: STARKEY PICASSO 1600 CIC
• 00842318166968: STARKEY PICASSO 2000 CIC
• 00842318166951: STARKEY PICASSO 2400 CIC
• 00842318166142: STARKEY PICASSO I1000 ITE
• 00842318166135: STARKEY PICASSO I1200 ITE
• 00842318166128: STARKEY PICASSO I1600 ITE
• 00842318166111: STARKEY PICASSO I2000 ITE
• 00842318166104: STARKEY PICASSO I2400 ITE
• 00842318166098: STARKEY PICASSO I1000 HALF SHELL
• 00842318166081: STARKEY PICASSO I1200 HALF SHELL
• 00842318166074: STARKEY PICASSO I1600 HALF SHELL
• 00842318166067: STARKEY PICASSO I2000 HALF SHELL
• 00842318166050: STARKEY PICASSO I2400 HALF SHELL
• 00842318166043: STARKEY PICASSO I1000 ITC
• 00842318166036: STARKEY PICASSO I1200 ITC
• 00842318166029: STARKEY PICASSO I1600 ITC
• 00842318166012: STARKEY PICASSO I2000 ITC
• 00842318166005: STARKEY PICASSO I2400 ITC
• 00842318165992: STARKEY PICASSO I1000 CIC
• 00842318165985: STARKEY PICASSO I1200 CIC
• 00842318165978: STARKEY PICASSO I1600 CIC
• 00842318165961: STARKEY PICASSO I2000 CIC
• 00842318160652: STARKEY PICASSO I2400 CIC