| Primary Device ID | 07540195025233 |
| NIH Device Record Key | 3a5fe0dd-d536-4e97-ba98-0d6b80b7f51a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAREvent DRA |
| Version Model Number | 01CV3000-DRA |
| Catalog Number | 01CV3000-DRA |
| 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 | 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 |
| Phone | 1-800-387-3405 |
| cs@otwo.com |
| Weight | 0.45 Kilogram |
| Height | 2.9 Inch |
| Width | 2.5 Inch |
| Length | 5.5 Inch |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540195025233 [Direct Marking] |
| GS1 | 07540195025240 [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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-26 |
| 07540195025233 | CAREvent DRA hand held automatic resuscitator is pneumatically powered, time/volume cycled venti |
| 07540195025097 | CAREvent DRA hand held automatic resuscitator is pneumatically powered, time/volume cycled venti |