| Primary Device ID | 10887709128009 |
| NIH Device Record Key | de7ed239-1111-4213-95d0-0c9792540056 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ICU Medical, Inc. |
| Version Model Number | PA01-XS |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| GS1 | 00887709128002 [Primary] |
| GS1 | 10887709128009 [Package] Contains: 00887709128002 Package: Case [30 Units] In Commercial Distribution |
| LHI | Set, i.V. Fluid transfer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-05 |
| Device Publish Date | 2025-04-25 |
| 10887709128078 | GTIN for B2229, 92" (234 cm) Appx 10.4 ml 15 Drop Admin Set w/5.0 Micron Filter, Inj Site, Spin |
| 10887709127361 | GTIN for MC330716, 1/EA |
| 10887709127354 | GTIN for B33984, 1/EA |
| 10887709128092 | GTIN for 46117-40, 1/EA |
| 10887709128061 | GTIN for CH-19, 1/EA |
| 10887709128009 | GTIN for PA01-XS, 46" (117 cm) Single Lead Transfer Set w/Clamp, Luer Lock, 1/EA |
| M335400031 | Plum Duo 1.2 Infusion System |
| M335400011 | Plum Solo 1.0 Infusion System |
| 10887709128221 | GTIN for AM3130, 1/EA |