| Primary Device ID | 00627908010018 |
| NIH Device Record Key | 1b19458a-cd17-40aa-a8ff-2ef6d6491785 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integrity V500 |
| Version Model Number | V500 |
| Company DUNS | 201740425 |
| Company Name | Vivosonic Inc |
| 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 | 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 | 00627908010018 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-21 |
| Device Publish Date | 2016-09-23 |
| 00062790820015 | Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is com |
| 00062790810016 | Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is |
| 00627908020017 | Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is com |
| 00627908010018 | Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is |