ICU MEDICAL, INC.

FDA Device Registration & Listing · SAN DIEGO, CA, US · Registration 2024064

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2024064
FEI Number
2024064
Entity Name
ICU MEDICAL, INC.
City/State/Country
SAN DIEGO, CA, US
Establishment Address
13520 EVENING CREEK DRIVE NORTH, SUITE 200, SAN DIEGO, CA 92128, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ICU MEDICAL, INC. (Owner Number: 2025816)
Owner / Operator Contact Address
951 Calle Amanecer, --, San Clemente, CA 92673, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K042081
PMA Number
N/A

All Registered Proprietary Names

Plum Duo Precision IV Pump ICU Medical MedNet Medication Management Suite LifeShield™ Infusion Safety Software Suite PLUM XL Infusion System LifeShield™ Infusion Safety Software Suite PLUM XL Infusion System Lifecare PCA Infusion system Lifecare 5000 Infusion System PLUM 360 Infusion System Plum DuoTM Infusion System PLUM 360 Infusion System PLUM A+ Infusion System Infusion System LifeShield™ Infusion Safety Software Suite PLUM A+ Infusion System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRN Pump, Infusion General Hospital Class 2 880.5725 2025-04-07
FRN Pump, Infusion General Hospital Class 2 880.5725 2017-02-19
PHC Infusion Safety Management Software General Hospital Class 2 880.5725 2025-04-07
FRN Pump, Infusion General Hospital Class 2 880.5725 2017-02-19
PHC Infusion Safety Management Software General Hospital Class 2 880.5725 2026-04-07
FRN Pump, Infusion General Hospital Class 2 880.5725 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
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
FRN Pump, Infusion General Hospital Class 2 880.5725 2023-09-07
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
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
PHC Infusion Safety Management Software General Hospital Class 2 880.5725 2023-08-28
FRN Pump, Infusion General Hospital Class 2 880.5725 2017-02-17

Official Correspondent

Michelle Doherty

US Agent Details

No US Agent registered (Local establishment).

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
1713468 ICU MEDICAL, INC Salt Lake City, UT, US
3013319212 ICU MEDICAL, INC. Lake Forest, IL, US
9615050 ICU Medical Costa Rica Ltd. La Aurora de Heredia, CR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K913718 Abbott Laboratories PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED 1991-10-30
K840616 Advanced Bio Systems, Inc. MINI-PUMP U-100 1984-03-30
K850183 Deltec Systems, Inc. CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M 1985-03-13
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2012 Hospira Inc. 2
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11.3 d) list 20679 - Hospira MedNet Software e) list 20792 - Driver Product Usage: The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system.
Z-0010-2012 Hospira Inc. 2
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+3 is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+3 a convenient and cost-effective infusion system.
Z-0027-2010 Hospira Inc 2
Plum A+3 Infusion System with Hospira Mednet, list # 20678-04-01, 20678-04-03, 20678-04-51, 20678-04-77, 20678-04-81, 20678-04-05, 20678-04-53; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
Z-0028-2010 Hospira Inc 2
Plum A+ Infusion System with Hospira Mednet, list #s 20679-04-01, 20679-04-03, 20679-04-05, 20679-04-51, 20679-04-77, 20679-04-79, 20679-04-81, 20792-04-01, 20792-04-03, 20792-04-05, 20792-04-51, 20792-04-53, 20792-04-77, 20792-04-79, 20792-04-81, 20792-04-83, 207929-04-87, 20792-04-55; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
Z-0001-2011 Baxter Healthcare Corp. Rt. 2
Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024064. Last updated year: 2026. Please use registration number 2024064 when referencing this establishment in official correspondence.
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