| Primary Device ID | 10850038863057 |
| NIH Device Record Key | 63bcf05c-e998-4d6a-8d40-296950ba83ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fresnius Kabi AG |
| Version Model Number | FK50030S |
| Company DUNS | 969484237 |
| Company Name | Directmed, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10850038863057 [Primary] |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-08 |
| Device Publish Date | 2023-10-31 |
| 10850038863064 | 60” Minibore Extension Set with slide clamp, male luer-lock and female luer |
| 10850038863057 | 30” Minibore Extension Set with slide clamp, male luer-lock and female luer |
| 10850038863040 | 18" Standard bore Extension Set with 1.2 Micron Filter, pinch clamp, male luer-lock and female |
| 10850038863033 | 18" Standard bore Extension Set with 0.2 Micron Filter, pinch clamp, male luer-lock and female |
| 00850038863067 | 60” Minibore Extension Set with slide clamp, male luer-lock and female luer |
| 00850038863050 | 30” Minibore Extension Set with slide clamp, male luer-lock and female luer |
| 00850038863043 | 18" Standard bore Extension Set with 1.2 Micron Filter, pinch clamp, male luer-lock and female |
| 00850038863036 | 18" Standard bore Extension Set with 0.2 Micron Filter, pinch clamp, male luer-lock and female |