| Primary Device ID | 00850049194211 |
| NIH Device Record Key | 248ba873-0a13-4865-8862-ca1e325b0bb0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NoviMed Hearing |
| Version Model Number | 99-0007-06 |
| Company DUNS | 117003805 |
| Company Name | Novidan, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com | |
| Phone | 855-668-4326 |
| service@novimedhearing.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850049194211 [Primary] |
| QUF | Hearing Aid, Air-Conduction, 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 | 2023-08-04 |
| Device Publish Date | 2023-07-27 |
| 00850049194068 | Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter, pair, slate color, 312 b |
| 00850049194051 | Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter, pair, slate color, 312 b |
| 00850049194044 | Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter, pair, beige in color, 31 |
| 00850049194211 | Pro OTC RIC Hearing Aids, Pair - Charcoal |
| 00850049194204 | Pro OTC RIC Hearing Aids, Pair - Slate |
| 00850049194198 | Pro OTC RIC Hearing Aids, Pair - Beige |
| 00850049194129 | BTE OTC Hearing Aids, Pair - Charcoal |
| 00850049194112 | BTE OTC Hearing Aids, Pair - Slate |
| 00850049194105 | BTE OTC Hearing Aids, Pair - Beige |
| 00850049194457 | Pro Rechargeable OTC Hearing Aids - Graphite Pair |
| 00850049194440 | Pro Rechargeable OTC Hearing Aids - Beige Pair |
| 00850049194433 | Pro Rechargeable OTC Hearing Aids - Glacier Pair |
| 00850049194365 | Pro Wireless Rechargeable OTC Hearing Aids - Graphite Pair |
| 00850049194358 | Pro Wireless Rechargeable OTC Hearing Aids - Beige Pair |
| 00850049194341 | Pro Wireless Rechargeable OTC Hearing Aids - Glacier Pair |