| Primary Device ID | B14360200791 |
| NIH Device Record Key | 17df4c65-da80-4036-b361-0336ab4735d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium Study Kit |
| Version Model Number | Proact - Single |
| Catalog Number | 602-0079 |
| Company DUNS | 557510625 |
| Company Name | Cleveland Medical Devices Inc. |
| 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 | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B14360200791 [Primary] |
| HIBCC | B14360200802 [Package] Package: Box [10 Units] In Commercial Distribution |
| HIBCC | B14360200812 [Package] Package: Box [25 Units] In Commercial Distribution |
| GWQ | Full-Montage Standard Electroencephalograph |
| 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 | 2016-09-23 |
| B14360201282 | Single use, premium study kit with two XXlarge ReadyRip Belts |
| B14360201252 | Single use, premium study kit with two Xlarge ReadyRip Belts |
| B14360201222 | Single use, premium study kit with two large ReadyRip Belts |
| B14360201141 | Single use, premium study kit extra extra large. |
| B14360201111 | Single use, premium study kit extra large. |
| B14360201081 | Single use, premium study kit large. |
| B14360200791 | Single use, proact premium study kit. |