| Primary Device ID | 15060491619817 |
| NIH Device Record Key | cd900f1e-8c4c-4613-b41d-35e4a25001fe |
| Commercial Distribution Discontinuation | 2025-02-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | CMO8 Adult PMP Oxygenator with Tubing Pack |
| Version Model Number | CME40009 |
| Catalog Number | CME40009 |
| Company DUNS | 236289299 |
| Company Name | CHALICE MEDICAL LIMITED |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light. |