| Primary Device ID | 00858177007106 |
| NIH Device Record Key | 1985d730-4153-4b92-9d18-ca9d9c2daab3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | hi Health |
| Version Model Number | BTE Powerplus Wireless |
| Catalog Number | 93300-000, 001 |
| Company DUNS | 002345767 |
| Company Name | INTRICON CORPORATION |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858177007106 [Primary] |
| OSM | Hearing Aid, Air Conduction With Wireless Technology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-05-14 |
| Device Publish Date | 2018-04-13 |
| 00858177007106 | Wireless Hearing Aid |
| 00858177007090 | Wireless Hearing Aid |