| Primary Device ID | 06009900487847 |
| NIH Device Record Key | 6d5f9725-d11b-4b09-a191-8c9b9d04267f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KUDUwave |
| Version Model Number | KUDUwave Prime TMP |
| Company DUNS | 557373018 |
| Company Name | EMOYODOTNETZA (PTY) LTD |
| 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 | 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06009900487847 [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 | 2019-05-10 |
| Device Publish Date | 2019-05-02 |
| 06009900487861 | An audiometer or automated audiometer is an electroacoustic device that produces controlled leve |
| 06009900487854 | An audiometer or automated audiometer is an electroacoustic device that produces controlled leve |
| 06009900487847 | An audiometer or automated audiometer is an electroacoustic device that produces controlled leve |
| 06009900487830 | An audiometer or automated audiometer is an electroacoustic device that produces controlled leve |
| 06009900487823 | An audiometer or automated audiometer is an electroacoustic device that produces controlled leve |
| 06009900487816 | An audiometer or automated audiometer is an electroacoustic device that produces controlled leve |