| Primary Device ID | 00840619089894 |
| NIH Device Record Key | 1e372740-eb95-4114-857b-cf7c5cddb5e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DianaTM Automated Drug Compounding System |
| Version Model Number | CL5300 |
| Catalog Number | CL5300 |
| Company DUNS | 118380146 |
| Company Name | ICU MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com | |
| Phone | +1(866)829-9025 |
| customerservice@icumed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840619089894 [Primary] |
| NEP | System/device, pharmacy compounding |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-28 |
| Device Publish Date | 2024-02-20 |
| 00840619091590 | Diana Automated Drug Compounding System |
| 00840619090876 | Diana Automated Drug Compounding System |
| 00840619089894 | Diana Automated Drug Compounding System |
| 00840619065058 | Diana Automated Drug Compounding System |
| 00840619054908 | Diana Automated Drug Compounding System |