77734239

GUDID 09120041051203

headband, BC-receivers, monaural; apollon, hearing system

BHM-Tech Produktionsgesellschaft m.b.H.

Head-worn bone-conduction hearing aid

• Primary Device ID: 09120041051203
• NIH Device Record Key: b07e537e-721c-4b4e-bc6e-952f546e9fa6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BC-HEADBAND-PLASTIC-MONAURAL/WS
• Catalog Number: 77734239
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120041051203 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-09-20

Devices Manufactured by BHM-Tech Produktionsgesellschaft m.b.H.

• 09120041051500 - BC-1: 2020-10-06 Audiometric receiver with headband
• 09120041051661 - BC-1: 2020-10-06 Audiometric receiver with headband
• 09120041050015 - AN-Evo1: 2020-04-06 AN-Evo1, left, brown, bone-conduction hearing system
• 09120041050022 - AN-Evo1: 2020-04-06 AN-Evo1, right, brown, bone-conduction hearing system
• 09120041050039 - AN-Evo1: 2020-04-06 AN-Evo1, left, black, bone-conduction hearing system
• 09120041050046 - AN-Evo1: 2020-04-06 AN-Evo1, right, black, bone-conduction hearing system
• 09120041050077 - contact star evo1: 2020-04-06 contact star evo1, left, brown, bone-conduction hearing system
• 09120041050084 - contact star evo1: 2020-04-06 contact star evo1, right, brown, bone-conduction hearing system