| Primary Device ID | 05060396171116 |
| NIH Device Record Key | 45a80bf1-5cdd-4b7b-bec5-8548abe13f52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Otoport/Otocheck Download Cable (Locking) |
| Version Model Number | OP-CAB-LOCK |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| enquiries@otodynamics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060396171116 [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 | 2019-11-04 |
| Device Publish Date | 2019-10-25 |
| 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 |