MICROTECH

GUDID 00842318188144

STARKEY LABORATORIES, INC.

Air-conduction hearing aid, canal

• Primary Device ID: 00842318188144
• NIH Device Record Key: 577ba24f-235d-4201-a28e-0311db9ab7fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICROTECH
• Version Model Number: MICROTECH ENVY AI 1600 CIC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842318188144 [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: 2025-07-04
• Device Publish Date: 2025-06-26

On-Brand Devices [MICROTECH]

• 00842318168399: MICROTECH PORTRAIT 1000 IIC
• 00842318168382: MICROTECH PORTRAIT 1200 IIC
• 00842318168375: MICROTECH PORTRAIT 1600 IIC
• 00842318168368: MICROTECH PORTRAIT 2000 IIC
• 00842318168351: MICROTECH PORTRAIT 2400 IIC
• 00842318168146: MICROTECH PORTRAIT I1000 IIC
• 00842318168139: MICROTECH PORTRAIT I1200 IIC
• 00842318168122: MICROTECH PORTRAIT I1600 IIC
• 00842318168115: MICROTECH PORTRAIT I2000 IIC
• 00842318168108: MICROTECH PORTRAIT I2400 IIC
• 00842318167743: MICROTECH PORTRAIT 1000 ITE
• 00842318167736: MICROTECH PORTRAIT 1200 ITE
• 00842318167729: MICROTECH PORTRAIT 1600 ITE
• 00842318167712: MICROTECH PORTRAIT 2000 ITE
• 00842318167705: MICROTECH PORTRAIT 2400 ITE
• 00842318167699: MICROTECH PORTRAIT 1000 HALF SHELL
• 00842318167682: MICROTECH PORTRAIT 1200 HALF SHELL
• 00842318167675: MICROTECH PORTRAIT 1600 HALF SHELL
• 00842318167668: MICROTECH PORTRAIT 2000 HALF SHELL
• 00842318167651: MICROTECH PORTRAIT 2400 HALF SHELL
• 00842318167644: MICROTECH PORTRAIT 1000 ITC
• 00842318167637: MICROTECH PORTRAIT 1200 ITC
• 00842318167620: MICROTECH PORTRAIT 1600 ITC
• 00842318167613: MICROTECH PORTRAIT 2000 ITC
• 00842318167606: MICROTECH PORTRAIT 2400 ITC
• 00842318167590: MICROTECH PORTRAIT 1000 CIC
• 00842318167583: MICROTECH PORTRAIT 1200 CIC
• 00842318167576: MICROTECH PORTRAIT 1600 CIC
• 00842318167569: MICROTECH PORTRAIT 2000 CIC
• 00842318167552: MICROTECH PORTRAIT 2400 CIC
• 00842318166746: MICROTECH PORTRAIT I1000 ITE
• 00842318166739: MICROTECH PORTRAIT I1200 ITE
• 00842318166722: MICROTECH PORTRAIT I1600 ITE
• 00842318166715: MICROTECH PORTRAIT I2000 ITE
• 00842318166708: MICROTECH PORTRAIT I2400 ITE
• 00842318166692: MICROTECH PORTRAIT I1000 HALF SHELL
• 00842318166685: MICROTECH PORTRAIT I1200 HALF SHELL
• 00842318166678: MICROTECH PORTRAIT I1600 HALF SHELL
• 00842318166661: MICROTECH PORTRAIT I2000 HALF SHELL
• 00842318166654: MICROTECH PORTRAIT I2400 HALF SHELL
• 00842318166647: MICROTECH PORTRAIT I1000 ITC
• 00842318166630: MICROTECH PORTRAIT I1200 ITC
• 00842318166623: MICROTECH PORTRAIT I1600 ITC
• 00842318166616: MICROTECH PORTRAIT I2000 ITC
• 00842318166609: MICROTECH PORTRAIT I2400 ITC
• 00842318166593: MICROTECH PORTRAIT I1000 CIC
• 00842318166586: MICROTECH PORTRAIT I1200 CIC
• 00842318166579: MICROTECH PORTRAIT I1600 CIC
• 00842318166562: MICROTECH PORTRAIT I2000 CIC
• 00842318166555: MICROTECH PORTRAIT I2400 CIC