| Primary Device ID | 16704820000073 |
| NIH Device Record Key | 95f0b460-efaf-4a09-b9bc-58dd4c3ec91e |
| Commercial Distribution Discontinuation | 2016-09-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ook cocoon |
| Version Model Number | FL36 ook cocoon |
| Catalog Number | FL36 |
| Company DUNS | 249675476 |
| Company Name | Umano Medical 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 | 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 | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |