| Primary Device ID | 05711781004228 |
| NIH Device Record Key | 57e015d5-4c83-4cf4-a102-555967274a64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Measure by Otometrics |
| Version Model Number | AUD-HF & Wireless REM & Speech Mapping Package |
| Catalog Number | 100.423 |
| 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 | true |
| 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 |