| Primary Device ID | 10810020440161 |
| NIH Device Record Key | f5a80a37-e92a-448f-85b2-5cfc32d0b095 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly |
| Version Model Number | 4R2353G |
| Catalog Number | 4R2353G |
| Company DUNS | 315654579 |
| Company Name | Fresenius Kabi AG |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |