BC-1 77735020

GUDID 09120041051500

Audiometric receiver with headband

BHM-Tech Produktionsgesellschaft m.b.H.

Auditory cranial bone vibrator

• Primary Device ID: 09120041051500
• NIH Device Record Key: 7b567b40-11db-431c-ba7f-145c55ebf281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BC-1
• Version Model Number: BC-1-BONE-W-HEADBAND
• Catalog Number: 77735020
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at
• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at
• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at
• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at
• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at
• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at
• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at
• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at
• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at
• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120041051500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102199

FDA Product Code

• LXB: Hearing Aid, Bone Conduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-10-06
• Device Publish Date: 2018-05-24

On-Brand Devices [BC-1]

• 09120041051661: Audiometric receiver with headband
• 09120041051500: Audiometric receiver with headband