Otoport Keypad Mat

GUDID 05060396172854

Keypad Mat service part for Otoport/Otocheck

OTODYNAMICS LIMITED

Evoked-potential audiometer

• Primary Device ID: 05060396172854
• NIH Device Record Key: d233cc53-c0ac-46bc-b4e9-b7c74bab6683
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otoport Keypad Mat
• Version Model Number: OP-KPAD-KIT
• Company DUNS: 235908050
• Company Name: OTODYNAMICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060396172854 [Primary]

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: 2023-05-15
• Device Publish Date: 2023-05-05

Devices Manufactured by OTODYNAMICS LIMITED

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• 05060396171536 - OtoNova Wireless Charging Pad: 2024-08-28 Wireless Charging Pad for OtoNova/OtoNova Pro. WPC (Qi) specification v1.2
• 05060396172243 - XPD Ear Probe: 2024-08-28 Next generation 'X-series' general purpose ear probe for TEOAE and DPOAE hearing screening/analysis, auditory stimulus for AABR
• 05060396172359 - ABR Electrode Cable (SNAP) for OtoNova Pro: 2024-08-28 ABR electrode cable for use with 4mm SNAP electrodes, length 44"/1.1M, Red/Black/White color coding, straight 4-pin yellow plug,
• 05060396172366 - ABR Electrode Cable (TAB) for OtoNova Pro: 2024-08-28 ABR electrode cable for use with TAB electrodes, length 44"/1.1M, Red/Black/White color coding, straight yellow 4-pin plug, for
• 05060396172809 - OtoNova Battery Assembly Service Kit: 2024-08-28 OtoNova V1/V2/Pro Battery Assembly Service Kit (for authorised dealers/repair centers only)