| Primary Device ID | 05711117027600 | 
| NIH Device Record Key | 76f01454-4ba0-4968-a791-30a8622895e5 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Amplivox | 
| Version Model Number | Assortment box Amplivox | 
| Company DUNS | 306308354 | 
| Company Name | Interacoustics A/S | 
| 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 | true | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | false | 
| Serial Number | false | 
| 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 | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05711117027600 [Primary] | 
| ETT | Cushion, Earphone (For Audiometric Testing) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2025-06-30 | 
| Device Publish Date | 2022-12-08 | 
| 05711117027600 | Assortment box Amplivox | 
| 05060488903106 | Ear tips 8-15 mm mushroom | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AMPLIVOX  85089022  3931020 Live/Registered | AmpliVox Sound Systems, L.L.C. 2010-07-20 | 
|  AMPLIVOX  77559944  3794009 Live/Registered | Amplivox Limited 2008-09-02 | 
|  AMPLIVOX  72329213  0914009 Dead/Expired | AMPLIVOX LIMITED 1969-06-05 |