Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615050

FEI Number

3002999813

Entity Name

ICU Medical Costa Rica Ltd.

City/State/Country

La Aurora de Heredia, CR

Establishment Address

1 Km Noreste del Centro Comercial Real Cariari, ZONA FRANCA GLOBAL Park, La Aurora de Heredia --, CR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ICU MEDICAL, INC. (Owner Number: 2025816)

Owner / Operator Contact Address

951 Calle Amanecer, --, San Clemente, CA 92673, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142367

PMA Number

N/A

All Registered Proprietary Names

Lifecare PCA Infusion system Sapphire Sets CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Ad Infusion Set Plum DuoTM Infusion System Extension Set THORACENTESIS SET, 30 Inch PLUM A+ Infusion System Extension Set PLUM A+ Infusion System Extension Set Plum Solo Precision IV Pump Plum Duo Precision IV Pump Lifecare PCA Infusion System Lifecare 5000 Infusion System Two-Way Transfer Device PLUM XL Infusion System Burette Set Medfusion Sapphire Set Empty Container and Infusion Set PLUM 360 Infusion System Extension Set PLUM 360 Infusion System Administration Set Administration Sets: Primary Sets, Extension Sets, Burette Sets, Blood Sets Irrigation Set Infusion Pump System with Administration Set Primary Set Sapphire Sets Blood Set PLUM A+ Infusion System PLUM XL Infusion System Extension Set Infusion Set Primary Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2023-12-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-12-04
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2023-12-04
PYR	Neuraxial Administration Set - Intrathecal Delivery	General Hospital	Class 2	880.5440	2023-12-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-21
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2023-09-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
ODA	Endoscopic Central Control Unit	Gastroenterology, Urology	Class 2	876.1500	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-04-07
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-04-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2018-04-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2024-08-19
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-08-19
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2017-08-28
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-04-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-04-11
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2017-04-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2017-02-21
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-17

Official Correspondent

Michelle Doherty

US Agent Details

Michelle Doherty Business: ICU MEDICAL, INC. Email: michelle.doherty@icumed.com Phone: (949) 3706562

Related Public Records

Same Entity

ICU MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9617594	ICU MEDICAL DE MEXICO, S. de R.L. de C.V.	ENSENADA, Baja California, MX
2025816	ICU MEDICAL, INC.	SAN CLEMENTE, CA, US
2024064	ICU MEDICAL, INC.	SAN DIEGO, CA, US
1713468	ICU MEDICAL, INC	Salt Lake City, UT, US
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2012	Smiths Medical ASD, Inc.	2	Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615050. Last updated year: 2026. Please use registration number 9615050 when referencing this establishment in official correspondence.