| Primary Device ID | 07540195025110 |
| NIH Device Record Key | 049a1bcb-69b6-464b-a6d2-12ad6bcf331d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAREvent ALS |
| Version Model Number | 01CV3100 |
| Catalog Number | 01CV3100 |
| Company DUNS | 206449154 |
| Company Name | O-Two Medical Technologies 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 |
| Phone | 1-800-387-3405 |
| cs@otwo.com |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540195025110 [Primary] |
| BTL | Ventilator, Emergency, Powered (Resuscitator) |
| 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 | 2015-10-26 |
| 07540195025165 | CAREvent ALS hand held automatic resuscitator is pneumatically powered, time/volume cycled venti |
| 07540195025141 | CAREvent ALS kit 01CV3212 contains a CAREvent ALS resuscitator, a pressure regulator, and an asp |
| 07540195025134 | CAREvent ALS kit 01CV3200 contains a CAREvent ALS resuscitator and a pressure regulator in a car |
| 07540195025127 | CAREvent ALS kit 01CV3112 contains a CAREvent ALS resuscitator, a pressure regulator, and an asp |
| 07540195025110 | CAREvent ALS kit 01CV3100 contains a CAREvent ALS resuscitator and a pressure regulator. CAREven |