| Primary Device ID | M335400021 |
| NIH Device Record Key | 93a24d2a-1b5b-43b5-88ee-ca3215827157 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plum Duo Infusion System |
| Version Model Number | 1.1 |
| Catalog Number | 40002 |
| Company DUNS | 118380146 |
| Company Name | ICU MEDICAL, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M335400021 [Primary] |
| FRN | Pump, infusion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-23 |
| Device Publish Date | 2023-10-13 |
| 10887709128511 - Bivona | 2024-10-09 FT24GN35NGE078N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile |
| 10887709128528 - Bivona | 2024-10-09 FT24GN35NSE226NBivona DI Template: Non-Adjustable-Wired_Non-Sterile |
| 10887709128535 - Bivona | 2024-10-09 FT24GN25NSA003N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile |
| 10887709128542 - Bivona | 2024-10-09 FT24HN60NGF004N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile |
| 10887709128559 - Bivona | 2024-10-09 FT24HN35NGE005N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile |
| 10887709128566 - Bivona | 2024-10-09 XT24HS35NGZ006N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile |
| 10887709128573 - Bivona | 2024-10-09 AU24HS80NSC007N Bivona DI Template: Adjustable Non-Sterile |
| 10887709128580 - Bivona | 2024-10-09 FT24HN55NSF008N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile |