| Primary Device ID | 05713315008757 |
| NIH Device Record Key | bac75dd7-05f2-4c5d-9e35-b8e1ad543be0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ICS |
| Version Model Number | LOOP BACK TESTER, EP 200 |
| Catalog Number | 8-40-00800 |
| Company DUNS | 306633756 |
| Company Name | Gn Otometrics A/S |
| 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 | true |
| Serial Number | false |
| 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 | 05713315008757 [Primary] |
| GWJ | Stimulator, Auditory, Evoked Response |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-20 |
| Device Publish Date | 2021-08-12 |
| 05713315009266 | AirCal Caloric Stimulator, Extended (Extended length - 4m) |
| 05713315009259 | AirCal Caloric Stimulator, Extended (Extended length - 4m) |
| 05713315009242 | AirCal Caloric Stimulator, Extended (Extended length - 4m) |
| 05713315009235 | AirCal Caloric Stimulator (Standard length - 3m) |
| 05713315008788 | Preamp Lanyard for ICS Chartr EP 200 |
| 05713315008771 | Preamp Shoulder Harness for ICS Chartr EP 200 |
| 05713315008764 | Starter Kit for ICS Chartr EP 200 |
| 05713315008757 | Loop Back Tester for ICS Chartr EP 200 |
| 05713315008740 | Pre-Amp for ICS Chartr EP 200 |