Data / Medical devices / Costa Rica / ICU Medical Costa Rica Ltd.
ICU Medical Costa Rica Ltd.: FDA-registered device maker in La Aurora de Heredia, Costa Rica, 39 510(k) clearances
ICU Medical Costa Rica Ltd. is registered with the FDA (registration 9615050) in La Aurora de Heredia, Costa Rica. It lists 12 device types. The FDA files 39 510(k) clearances under its listings, the newest dated August 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615050
- FEI number
- 3002999813
- Address
- 1 Km Noreste del Centro Comercial Real Cariari ZONA FRANCA GLOBAL Park, La Aurora de Heredia, Costa Rica, --
- Owner or operator
- ICU MEDICAL, INC. (2025816)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 17, 2017
- Registered through
- 2026
- Brand names listed
- Administration Set, Administration Sets: Primary Sets, Extension Sets, Burette Sets, Blood Sets, Blood Set, Burette Set, CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Ad, CADD®-Solis VIP Ambulatory Infusion System, Empty Container and Infusion Set, Extension Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Central Control Unit | ODA | 2 | Manufacturer | accessdata.fda.gov |
| Infusion Safety Management Software | PHC | 2 | Manufacturer | accessdata.fda.gov |
| Neuraxial Administration Set - Intrathecal Delivery | PYR | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Pca | MEA | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 24, 2023 | K223607 | Plum Duo Infusion System | FRN | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 25, 2017 | K171346 | Sapphire Sets | MRZ | Substantially Equivalent | Icu Medical | accessdata.fda.gov |
| August 24, 2017 | K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) | MEA | Substantially Equivalent | Smiths Medical Ads, Inc. | accessdata.fda.gov |
| March 28, 2017 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 6, 2017 | K161036 | Hospira Extension Set, Hospira Primary Set | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 6, 2016 | K160492 | Hospira Sapphire Sets | MRZ | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| June 1, 2016 | K160870 | Hospira Administration Sets | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| April 8, 2016 | K143612 | LifeCare PCA Infusion System | MEA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 19, 2016 | K151969 | Hospira Extension Sets | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| March 4, 2015 | K143087 | Hospira Blood Set | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| February 25, 2015 | K143015 | Hospira Primary Sets | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 16, 2015 | K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 15, 2015 | K142622 | IV Administration | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 9, 2015 | K142974 | Extension Sets | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 11, 2014 | K141389 | SAPPHIRE INFUSION PUMP | FRN | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| December 8, 2014 | K142433 | Hospira Extension Set | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142367 | Hospira Primary Sets | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 5, 2014 | K141834 | SAPPHIRE ADMINISTRATION SET | FPA | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| January 24, 2014 | K133602 | ADD-VANTAGE ADDAPTOR | LHI | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| October 17, 2013 | K123049 | SAPPHIRE INFUSION PUMP | FRN | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| March 5, 2012 | K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 12, 2012 | K113683 | LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 29, 2011 | K111386 | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) | FRN | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| January 7, 2011 | K103224 | HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 10, 2010 | K103344 | INFUSION SETS | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 11, 2010 | K101677 | HOSPIRA INFUSION BLOOD SETS | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| April 24, 2007 | K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| April 21, 2006 | K060806 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 24, 2005 | K052052 | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| October 18, 2004 | K042800 | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | MEA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 24, 2004 | K042081 | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| April 6, 2001 | K010924 | MODIFICATION TO PLUM XL INFUSION PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 12, 1999 | K982159 | ABBOTT PLUM A+ INFUSION PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 18, 1996 | K952799 | ABBOTT XL3M INFUSION PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 3, 1994 | K941214 | LIFESHIELD EXTENSION SET | FPK | Substantially Equivalent | Abbott Mfg., Inc. | accessdata.fda.gov |
| May 28, 1991 | K911401 | ABBOTT LIFECARE 5000 PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 15, 1985 | K844077 | NUTRIMIX EMPTY CONTAINER | KPE | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 26, 1979 | K791774 | LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN | KPE | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 2, 1977 | K771228 | LIFECARE EMPTY CONTAINER | KPE | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Pump, Infusion
- All makers of Infusion Safety Management Software
- All makers of Pump, Infusion, Pca
- All makers of Accessories, Pump, Infusion
Updated August 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.