Otoport Binaural ABR Module (Upgrade)

GUDID 05060396171222

Binaural ABR module for use with existing Otoport/Otocheck to add ABR functionality in addition to OAE.

OTODYNAMICS LIMITED

Evoked-potential audiometer

• Primary Device ID: 05060396171222
• NIH Device Record Key: 2048e79d-7ead-4e7d-b784-51c75ebe3af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otoport Binaural ABR Module (Upgrade)
• Version Model Number: ABR-UG-BI
• Company DUNS: 235908050
• Company Name: OTODYNAMICS LIMITED
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 800 659 7776
• Email: enquiries@otodynamics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060396171222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143395

FDA Product Code

• EWO: Audiometer

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: 2019-11-04
• Device Publish Date: 2019-10-25

Devices Manufactured by OTODYNAMICS LIMITED

• 05060396172656 - ABR PSU PCB service kit: 2023-05-15 PSU PCB service kit for ABR Module Otoport/Otocheck
• 05060396172694 - ABR Amplifier & Control service kit: 2023-05-15 Amplifier & Control service kit for ABR Module Otoport/Otocheck
• 05060396172700 - ABR Case service kit - Bottom: 2023-05-15 Case service kit (Bottom section enclosure) for ABR Module Otoport/Otocheck
• 05060396172717 - ABR Case service kit - Top: 2023-05-15 Case service kit (Top section enclosure) for ABR Module Otoport/Otocheck
• 05060396172724 - ABR Feedthrough PCB service kit: 2023-05-15 Feedthrough PCB service kit for ABR Module Otoport/Otocheck
• 05060396172731 - ABR Case service kit – latch locking: 2023-05-15 Case service kit (Latch, locking) for ABR Module Otoport/Otocheck
• 05060396172748 - ABR Case service kit – latch non locking: 2023-05-15 Case service kit (Latch, non locking) for ABR Module Otoport/Otocheck
• 05060396172755 - Echoport USB Amplifier PCB: 2023-05-15 USB Amplifier PCB service part for Echoport