KIND 63099-H

GUDID 00842318174635

STARKEY LABORATORIES, INC.

Behind-the-ear air-conduction hearing aid

• Primary Device ID: 00842318174635
• NIH Device Record Key: 1a0a7ffb-d617-4514-9965-cf648944f8bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIND
• Version Model Number: KIND KINDEVO 3230 BTE 13
• Catalog Number: 63099-H
• 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 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
• 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	00842318174635 [Primary]

FDA Product Code

• OSM: Hearing aid, air conduction with wireless technology

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: 2019-04-22
• Device Publish Date: 2019-04-12

On-Brand Devices [KIND]

• 00842318130822: “KIND name” for Android
• 00842318130815: “KIND name” for iOS
• 00842318175908: KIND KINDEVO BTE 13
• 00842318175861: KIND KINDVITALO CROSBICROS BTE 13
• 00842318175786: KIND KINDVITALO 5400 RIC 312
• 00842318175694: KIND KINDEVO CROSBICROS RIC R
• 00842318175618: KIND KINDEVO 1430R RIC R
• 00842318175526: KIND KINDEVO 2430R RIC R
• 00842318175380: KIND KINDEVO 3430R RIC R
• 00842318175229: KIND KINDEVO 5430R RIC R
• 00842318175144: KIND KINDVITALO CROSBICROS RIC R
• 00842318174963: KIND KINDEVO CROSBICROS BTE 13
• 00842318174871: KIND KINDEVO 1230 BTE 13
• 00842318174772: KIND KINDEVO 2230 BTE 13
• 00842318174635: KIND KINDEVO 3230 BTE 13
• 00842318174475: KIND KINDEVO 5230 BTE 13
• 00842318174390: KIND KINDVITALO 5200 BTE 13
• 00842318174314: KIND KINDVITALO 1200 BTE 13
• 00842318174222: KIND KINDVITALO 2200 BTE 13
• 00842318174147: KIND KINDVITALO 3200 BTE 13
• 00842318173997: KIND KINDEVO CROSBICROS RIC 312
• 00842318173898: KIND KINDEVO 2430 RIC 312
• 00842318173805: KIND KINDEVO 1430 RIC 312
• 00842318173669: KIND KINDEVO 3430 RIC 312
• 00842318173508: KIND KINDEVO 5430 RIC 312
• 00842318173423: KIND KINDVITALO CROSBICROS RIC 312
• 00842318173348: KIND KINDVITALO 1400 RIC 312
• 00842318173256: KIND KINDVITALO 2400 RIC 312
• 00842318173171: KIND KINDVITALO 3400 RIC 312
• 00842318172822: KIND KINDVEVO 1430 MRIC 312
• 00842318172730: KIND KINDVEVO 2430 MRIC 312
• 00842318172594: KIND KINDVEVO 3430 MRIC 312
• 00842318172433: KIND KINDVEVO 5430 MRIC 312
• 00842318172259: KIND KINDVITALO 1400+ MRIC 312
• 00842318172167: KIND KINDVITALO 2400+ MRIC 312
• 00842318172082: KIND KINDVITALO 3400+ MRIC 312
• 00842318171931: KIND KINDVITALO 5400+ MRIC 312
• 00842318171832: KIND KINDVITALO 1400R RIC R
• 00842318171740: KIND KINDVITALO 2400R RIC R
• 00842318171665: KIND KINDVITALO 3400R RIC R
• 00842318171511: KIND KINDVITALO 5400R RIC R
• 00842318181596: KINDEVO 1630R
• 00842318181510: KINDEVO 2630R
• 00842318181435: KINDEVO 3630R
• 00842318181282: KINDEVO 5630R
• 00842318181206: KINDVITALO 1600R
• 00842318181121: KINDVITALO 2600R
• 00842318181046: KINDVITALO 3600R
• 00842318180834: KINDVITALO 5610R
• 00842318178268: KINDVITALO T410R