| Primary Device ID | 00840479400013 |
| NIH Device Record Key | d36d868d-8fd7-4cad-895f-2d25f0fcda8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | enableCV ProPlege Peripheral Retrograde Cardioplegia Device |
| Version Model Number | PR9 |
| Catalog Number | PR9 |
| Company DUNS | 119247843 |
| Company Name | ENABLECV 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 | 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool dry place. |