| Primary Device ID | 00046838505065 |
| NIH Device Record Key | 13d98b25-0c36-44cc-8f12-07413b2af903 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JVC |
| Version Model Number | EH-Z2000-H |
| Company DUNS | 117003805 |
| Company Name | Novidan, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00046838505065 [Primary] |
| GS1 | 10046838505062 [Package] Package: Box [4 Units] In Commercial Distribution |
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-15 |
| Device Publish Date | 2025-05-07 |
| 00046838505065 - JVC | 2025-05-15Self-Fit OTC Hearing Aid Pair, wireless, rechargeable, cool gray color |
| 00046838505065 - JVC | 2025-05-15 Self-Fit OTC Hearing Aid Pair, wireless, rechargeable, cool gray color |
| 00850049194464 - Novidan | 2024-12-03 Novidan Mobile Application - iOS |
| 00850049194471 - Novidan | 2024-12-03 Novidan Mobile Application - Android |
| 00850049194341 - NoviMed Hearing | 2024-06-20 Pro Wireless Rechargeable OTC Hearing Aids - Glacier Pair |
| 00850049194358 - NoviMed Hearing | 2024-06-20 Pro Wireless Rechargeable OTC Hearing Aids - Beige Pair |
| 00850049194365 - NoviMed Hearing | 2024-06-20 Pro Wireless Rechargeable OTC Hearing Aids - Graphite Pair |
| 00850049194433 - NoviMed Hearing | 2024-06-20 Pro Rechargeable OTC Hearing Aids - Glacier Pair |
| 00850049194440 - NoviMed Hearing | 2024-06-20 Pro Rechargeable OTC Hearing Aids - Beige Pair |