| Primary Device ID | 00816953022125 |
| NIH Device Record Key | 97befe81-9fba-45fd-97c2-3b3c9568f268 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E5311 Dome Bag 66cm |
| Version Model Number | E5311 |
| Catalog Number | E5311 |
| Company DUNS | 014464314 |
| Company Name | EXACT MEDICAL MANUFACTURING, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
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