| Primary Device ID | 05060396173295 |
| NIH Device Record Key | 2fc05604-1c84-4614-aa55-d9d3bcb67cb5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Otoport Pro Advanced Clinical |
| Version Model Number | OPRO-ADV-DT |
| 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 |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com | |
| Phone | 1-800-659-7776 |
| info@otodynamics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060396173295 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-25 |
| Device Publish Date | 2024-07-17 |
| 05060396171130 - Crib/bassinet device holster for OtoNova | 2024-08-28 Crib/bassinet device holster for OtoNova |
| 05060396171512 - Tablet Computer for OtoNova Pro | 2024-08-28 Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requi |
| 05060396171529 - OtoNova Charger | 2024-08-28 Medical Power Supply Unit for OtoNova Wireless Charging Pad |
| 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) |