AN-Evo1 77733106

GUDID 09120041050046

AN-Evo1, right, black, bone-conduction hearing system

BHM-Tech Produktionsgesellschaft m.b.H.

Head-worn bone-conduction hearing aid

• Primary Device ID: 09120041050046
• NIH Device Record Key: 8cffb123-d184-44cd-89e2-73fb2e787295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AN-Evo1
• Version Model Number: AN-EVO1/R/SW
• Catalog Number: 77733106
• 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: nice_2_hear_u@bhm-tech.at

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120041050046 [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

On-Brand Devices [AN-Evo1]

• 09120041050046: AN-Evo1, right, black, bone-conduction hearing system
• 09120041050039: AN-Evo1, left, black, bone-conduction hearing system
• 09120041050022: AN-Evo1, right, brown, bone-conduction hearing system
• 09120041050015: AN-Evo1, left, brown, bone-conduction hearing system