| Primary Device ID | 00817020020327 |
| NIH Device Record Key | d3e41204-7e96-4361-9bd9-324ee81d6d2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | USB Response Box |
| Version Model Number | M031501 |
| Company DUNS | 154870455 |
| Company Name | INTELLIGENT HEARING SYSTEMS CORP. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817020020327 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
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| 00817020020815 - SmartEP-ASSR Software | 2019-07-12 |
| 00817020020822 - SmartScreener-Plus2 Screener Launch | 2019-07-12 |
| 00817020020839 - SmartScreener-Plus2 AEP Module | 2019-07-12 |
| 00817020020846 - SmartScreener-Plus2 OAE Module | 2019-07-12 |