contact 77735201

GUDID 09120041052149

bone conduction hearing aid, BL/blue

BHM-Tech Produktionsgesellschaft m.b.H.

Bone-conduction hearing aid, head-worn

• Primary Device ID: 09120041052149
• NIH Device Record Key: 865e9a09-13f9-4cb5-a883-38c994951f7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: contact
• Version Model Number: contact mini
• Catalog Number: 77735201
• Company DUNS: 300632705
• Company Name: BHM-Tech Produktionsgesellschaft m.b.H.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: +43335920078
• Email: regulatory.request@bhm-tech.com
• Phone: +43335920078
• Email: regulatory.request@bhm-tech.com
• Phone: +43335920078
• Email: regulatory.request@bhm-tech.com
• Phone: +43335920078
• Email: regulatory.request@bhm-tech.com
• Phone: +43335920078
• Email: regulatory.request@bhm-tech.com
• Phone: +43335920078
• Email: regulatory.request@bhm-tech.com
• Phone: +43335920078
• Email: regulatory.request@bhm-tech.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120041052149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121793

FDA Product Code

• LXB: Hearing Aid, Bone Conduction

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: 2026-02-25
• Device Publish Date: 2026-02-17

On-Brand Devices [contact]

• 09120041059742: bone conduction hearing aid, ALPHA, BP/babypink
• 09120041059735: bone conduction hearing aid, ALPHA, BB/babyblue
• 09120041059728: bone conduction hearing aid, ALPHA, BL/blue
• 09120041059711: bone conduction hearing aid, ALPHA, RT/red
• 09120041059704: bone conduction hearing aid, ALPHA, SW/black
• 09120041059698: bone conduction hearing aid, D/with DAI, SW/black
• 09120041059681: bone conduction hearing aid, D/with DAI, RT/red
• 09120041059674: bone conduction hearing aid, D/with DAI, BP/babypink
• 09120041059667: bone conduction hearing aid, D/with DAI, BL/blue
• 09120041059650: bone conduction hearing aid, D/with DAI, BB/babyblue
• 09120041059612: bone conduction hearing aid, BP/babypink
• 09120041059605: bone conduction hearing aid, BB/babyblue
• 09120041059599: bone conduction hearing aid, BL/blue
• 09120041059582: bone conduction hearing aid, RT/red
• 09120041059575: bone conduction hearing aid, SW/black
• 09120041052323: bone conduction hearing aid, TEL/with telecoil, SW/black
• 09120041052316: bone conduction hearing aid, TEL/with telecoil, RT/red
• 09120041052309: bone conduction hearing aid, TEL/with telecoil, BL/blue
• 09120041052163: bone conduction hearing aid, SW/black
• 09120041052156: bone conduction hearing aid, RT/red
• 09120041052149: bone conduction hearing aid, BL/blue