| Primary Device ID | 00860000876261 |
| NIH Device Record Key | d45df803-4b12-4cff-ae9c-09e183b66cab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROSC-U Head Stabilizer |
| Version Model Number | A02-55-135 |
| Catalog Number | A02-55-135 |
| Company DUNS | 053006828 |
| Company Name | RESUSCITATION INTERNATIONAL, LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00860000876209 - ROSC-U System | 2019-12-23 Mechanical CPR system, including Battery Control Unit, Compressor, Torso Restraints (10 pk), Torso Restraints XL (5 pk), Battery |
| 00860000876216 - ROSC-U, Battery Control Unit | 2019-12-23 Battery Control Unit |
| 00860000876223 - ROSC-U, Compressor | 2019-12-23 Compressor Unit |
| 00860000876230 - ROSC-U, Disposables Pack (10) | 2019-12-23 Disposables Pack, 10 ea of Torso Restraints and Head Stabilizer Covers |
| 00860000876247 - ROSC-U, Disposables Pack (5) | 2019-12-23 Disposables Pack, 5 ea of XL Torso Restraints and Head Stabilizer Covers |
| 00860000876254 - ROSC-U Battery Charger | 2019-12-23 Battery Charger |
| 00860000876261 - ROSC-U Head Stabilizer | 2019-12-23Head Stabilizer used to limit head movement during resuscitation |
| 00860000876261 - ROSC-U Head Stabilizer | 2019-12-23 Head Stabilizer used to limit head movement during resuscitation |
| 00860000876278 - ROSC-U Carrying/Storage Case | 2019-12-23 Case used for carrying and/or storage of ROSC-U |