| Primary Device ID | 05711781001722 |
| NIH Device Record Key | 230a01b9-1305-40e4-bf83-b16ad6e7d629 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OTOPro By Auditdata |
| Version Model Number | OTOPro |
| Company DUNS | 310385849 |
| Company Name | Auditdata A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05711781001722 [Primary] |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2016-08-24 |
| 05711781004204 - Measure by Otometrics | 2025-11-24 2000-1 Fitting Unit Audiometer |
| 05711781004211 - Measure by Otometrics | 2025-11-24 2000-1 Fitting Unit Audiometer |
| 05711781004228 - Measure by Otometrics | 2025-11-24 2000-1 Fitting Unit Audiometer |
| 05711781004235 - Measure by Otometrics | 2025-11-24 2000-1 Fitting Unit Audiometer |
| 05711781004242 - Measure by Otometrics | 2025-11-24 2000-1 Fitting Unit Audiometer |
| 05711781004259 - Measure by Otometrics | 2025-11-24 2000-1 Fitting Unit Audiometer |
| 05711781004266 - Measure by Otometrics | 2025-11-24 2000-1 Fitting Unit Audiometer |
| 05711781004280 - Measure by Otometrics | 2025-11-24 2000-1 Fitting Unit Audiometer |