NUEAR NUE P2I

GUDID 00842318166548

STARKEY LABORATORIES, INC.

In-the-ear air-conduction hearing aid

• Primary Device ID: 00842318166548
• NIH Device Record Key: d09a397e-5dfd-4157-bab5-9d3ec567d79e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NUEAR
• Version Model Number: NUEAR CANVAS I1000 ITE
• Catalog Number: NUE P2I
• 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 Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• 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	00842318166548 [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: 2018-09-27
• Device Publish Date: 2018-08-27

On-Brand Devices [NUEAR]

• 00842318168344: NUEAR CANVAS 1000 IIC
• 00842318168337: NUEAR CANVAS 1200 IIC
• 00842318168320: NUEAR CANVAS 1600 IIC
• 00842318168313: NUEAR CANVAS 2000 IIC
• 00842318168306: NUEAR CANVAS 2400 IIC
• 00842318168092: NUEAR CANVAS I1000 IIC
• 00842318168085: NUEAR CANVAS I1200 IIC
• 00842318168078: NUEAR CANVAS I1600 IIC
• 00842318168061: NUEAR CANVAS I2000 IIC
• 00842318168054: NUEAR CANVAS I2400 IIC
• 00842318167545: NUEAR CANVAS 1000 ITE
• 00842318167538: NUEAR CANVAS 1200 ITE
• 00842318167521: NUEAR CANVAS 1600 ITE
• 00842318167514: NUEAR CANVAS 2000 ITE
• 00842318167507: NUEAR CANVAS 2400 ITE
• 00842318167491: NUEAR CANVAS 1000 HALF SHELL
• 00842318167484: NUEAR CANVAS 1200 HALF SHELL
• 00842318167477: NUEAR CANVAS 1600 HALF SHELL
• 00842318167460: NUEAR CANVAS 2000 HALF SHELL
• 00842318167453: NUEAR CANVAS 2400 HALF SHELL
• 00842318167446: NUEAR CANVAS 1000 ITC
• 00842318167439: NUEAR CANVAS 1200 ITC
• 00842318167422: NUEAR CANVAS 1600 ITC
• 00842318167415: NUEAR CANVAS 2000 ITC
• 00842318167408: NUEAR CANVAS 2400 ITC
• 00842318167392: NUEAR CANVAS 1000 CIC
• 00842318167385: NUEAR CANVAS 1200 CIC
• 00842318167378: NUEAR CANVAS 1600 CIC
• 00842318167361: NUEAR CANVAS 2000 CIC
• 00842318167354: NUEAR CANVAS 2400 CIC
• 00842318166548: NUEAR CANVAS I1000 ITE
• 00842318166531: NUEAR CANVAS I1200 ITE
• 00842318166524: NUEAR CANVAS I1600 ITE
• 00842318166517: NUEAR CANVAS I2000 ITE
• 00842318166500: NUEAR CANVAS I2400 ITE
• 00842318166494: NUEAR CANVAS I1000 HALF SHELL
• 00842318166487: NUEAR CANVAS I1200 HALF SHELL
• 00842318166470: NUEAR CANVAS I1600 HALF SHELL
• 00842318166463: NUEAR CANVAS I2000 HALF SHELL
• 00842318166456: NUEAR CANVAS I2400 HALF SHELL
• 00842318166449: NUEAR CANVAS I1000 ITC
• 00842318166432: NUEAR CANVAS I1200 ITC
• 00842318166425: NUEAR CANVAS I1600 ITC
• 00842318166418: NUEAR CANVAS I2000 ITC
• 00842318166401: NUEAR CANVAS I2400 ITC
• 00842318166395: NUEAR CANVAS I1000 CIC
• 00842318166388: NUEAR CANVAS I1200 CIC
• 00842318166371: NUEAR CANVAS I1600 CIC
• 00842318166364: NUEAR CANVAS I2000 CIC
• 00842318166357: NUEAR CANVAS I2400 CIC