| Primary Device ID | 04033133611016 |
| NIH Device Record Key | d03e2740-8ca4-4dc3-ae2d-3504255d7313 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Custodiol(R) |
| Version Model Number | 6 x 1000 ml |
| Company DUNS | 316512953 |
| Company Name | Dr. Franz Köhler Chemie GmbH |
| Device Count | 6 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04033133011014 [Unit of Use] |
| GS1 | 04033133611016 [Primary] |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2019-08-08 |
| 04033133610002 | 6 x 1000 ml |
| 04033133420007 | 4 x 2000 ml |
| 04033133250000 | 2 x 5000 ml |
| 04033133105003 | 10 x 500 ml |
| 04033133611016 | 6 x 1000 ml |
| 04033133020009 | 4 x 2000 ml |