| Primary Device ID | 07540195053007 |
| NIH Device Record Key | 8b4b4248-3c95-43f7-8b75-240ac8e6323f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STATVAC II Oxygen powered Aspirator |
| Version Model Number | 01AS9500 |
| Catalog Number | 01AS9500 |
| Company DUNS | 206449154 |
| Company Name | O-Two Medical Technologies Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | true |
| 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 |
| Phone | 1-800-387-3405 |
| cs@otwo.com |
| Total Volume | 8 Fluid Ounce |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540195053007 [Direct Marking] |
| GS1 | 07540195053014 [Primary] |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-08-23 |
| Device Publish Date | 2016-09-23 |
| 07540195053038 | The O-Two Statvac® II Aspirator is capable of effectively suctioning out excessive quantities o |
| 07540195053007 | The O-Two Statvac® II Aspirator is capable of effectively suctioning out excessive quantities o |