| Primary Device ID | 05711781002675 |
| NIH Device Record Key | 4123f437-c78e-42cf-8471-7de4d381f1df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Measure/Unity 4 |
| Version Model Number | 2000-1 Fitting Unit |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05711781002675 [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 | 2024-05-06 |
| Device Publish Date | 2024-04-26 |
| 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 |