| Primary Device ID | D806OSI581212 |
| NIH Device Record Key | ac42ec91-8a9d-4dfa-8492-14047b2ff223 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIZUHO OSI |
| Version Model Number | OSI5812-1 |
| Company DUNS | 196642151 |
| Company Name | MAYTEX CORPORATION |
| Device Count | 360 |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |