| Primary Device ID | 05060396173561 |
| NIH Device Record Key | aa8781e6-6981-4025-92a2-d867a8357ca4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Otoport Pro Analogue Front End PCB Service Kit |
| Version Model Number | OP2-ANALOG-KIT |
| 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 |
| 05060396172373 - ABR Electrode Cable V2 (SNAP) for Otoport V2/Pro | 2024-07-25 ABR electrodes cable for use with 4mm SNAP electrodes, length 47"/1.2m, Red/Black/White color coding, right-angle yellow 4-pin p |
| 05060396172380 - ABR Electrode Cable V2 (TAB) for Otoport V2/Pro | 2024-07-25 ABR electrodes cable for use with TAB electrodes, length 47"/1.2m, Red/Black/White color coding, right-angle yellow 4-pin plug, |
| 05060396173066 - ABR Electrode Cable V2 (NHSP) for Otoport V2/Pro | 2024-07-25 ABR electrodes cable for use with TAB electrodes, length 47"/1.2m, Black/Green/White colour coding for NHSP, right-angle yellow |
| 05060396173097 - Otoport Pro OAE+AABR instrument | 2024-07-25 Handheld, portable, Otoacoustic Emission (OAE) & Auditory Brainstem Response (AABR) analyser, for hearing screening applications |
| 05060396173189 - Otoport Pro Screener DP | 2024-07-25 Handheld, portable, Otoacoustic Emission (OAE) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, syste |
| 05060396173196 - Otoport Pro Screener TE | 2024-07-25 Handheld, portable, Otoacoustic Emission (OAE) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, syste |
| 05060396173202 - Otoport Pro Screener DP+TE | 2024-07-25 Handheld, portable, Otoacoustic Emission (OAE) analyser for hearing screening. Includes Otoport Pro instrument, ear probe, syste |
| 05060396173219 - Otoport Pro Screener AABR | 2024-07-25 Handheld, portable, Automated Auditory Brainstem Response (AABR) analyser for hearing screening. Includes Otoport Pro instrument |