Primary Device ID | 00860000876223 |
NIH Device Record Key | fbef9c2d-a8b8-487e-9acd-8d0cb4077d15 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ROSC-U, Compressor |
Version Model Number | A03-1C-000 |
Catalog Number | A03-1C-000 |
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 | false |
Lot Batch | false |
Serial Number | true |
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 | 2019-12-23Compressor 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 | 2019-12-23 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 |