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510(k) Data Aggregation

    K Number
    K242114
    Device Name
    Plum Solo™ Precision IV Pump
    Manufacturer
    ICU Medical Inc
    Date Cleared
    2025-04-02

    (257 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICU Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plum Solo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous. The Plum Solo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use. The Plum Solo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.
    Device Description
    The Plum Solo™ Precision IV Pump is a large volume pump (LVP) with one pump channel that can deliver fluid to a patient from 1 to 2 lines independently. The Plum Solo™ Precision IV Pump can only be used with dedicated PlumSet™ administration sets (not subject of this filing). The pump channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container. The fluid is delivered from the upstream lines either serially (piggyback) or concurrently through the cassette to the downstream line. The flow rate accuracy precision has been improved (lower allowed variance) by implementing the new motor mechanism, as well as increased precision for programming concentration, flow rate and VTBI entries. The overall delivery accuracy of the system has improved to +/- 3% per TIR 101 standard condition testing and +/-5% for non-standard conditions.
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    K Number
    K242115
    Device Name
    Plum Duo™ Precision IV Pump
    Manufacturer
    ICU Medical Inc.
    Date Cleared
    2025-04-02

    (257 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICU Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plum Duo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous. The Plum Duo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use. The Plum Duo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.
    Device Description
    The Plum Duo™ Precision IV Pump is a large volume pump (LVP) with two independent pump channels that can deliver fluid to a patient from 1 to 4 lines independently. In addition, although the channels can operate independently, patient parameters can be shared across the channels to aid in ease of programming. The Plum Duo™ Precision IV Pump can only be used with dedicated PlumSet™ administration sets (not subject of this filing). Each pump channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container. The fluid is delivered from the upstream lines either serially (piggyback) or concurrently through the cassette to the downstream line. Each pump channel cassette has an independent downstream line (patient line), so the clinician can connect each downstream line to a single infusion site or two separate infusion sites. The flow rate accuracy precision has been improved (lower allowed variance) by implementing the new motor mechanism, as well as increased precision for programming concentration, flow rate and VTBI entries. The overall delivery accuracy of the system has improved to +/- 3% per TIR 101 standard condition testing and +/-5% for non-standard conditions.
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    K Number
    K170110
    Device Name
    Diana Medication Transfer Set
    Manufacturer
    ICU MEDICAL INC
    Date Cleared
    2018-08-10

    (575 days)

    Product Code
    ONB
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICU MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diana ChemoLock Transfer Set is a sterile, single-use closed system transfer device used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.
    Device Description
    Diana ChemoLock Transfer Set is intended for use with the Diana Compounding System. It is a disposable, single use ancillary device for Pharmacy Compounding Devices (PCD). The transfer set is comprised of multiple components bonded together to form a single device. These components include the following: stopcock, tubing, ChemoLock, syringe, and cassette handle. When placed in the Diana Compounding System, the Diana ChemoLock Transfer Set allows the transfer of fluids from one container to the other container for reconstitution of lyophilized drug or transfer of stock drug solution to prepare medications. The purpose of this submission is to release a new closed system transfer device (CSTD) drug transfer set to be used with Diana Pharmacy Compounding System
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    K Number
    K152006
    Device Name
    Cogent Hemodynamic Monitoring System
    Manufacturer
    ICU MEDICAL INC.
    Date Cleared
    2016-05-05

    (289 days)

    Product Code
    DXQ, DQA, DXG
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICU MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cogent™ Hemodynamic Monitoring System (HMS) is intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. Suitability for use on a patient is up to the physician's judgment and the diameter to be used. The target population includes patients for whom hemodynamic monitoring will improve clinical care. The target populations are identical to those for the predicate devices and include: Critical Care Patients, Trauma Patients, Cardiac Surgery Patients. The Cogent™ HMS is intended for use with ICU Medical pulmonary artery catheters and central venous oximetry catheters, and with ICU Medical Cogent™ sensors. The Cogent™ HMS is intended to measure and calculate venous oxygen saturation in patients. PulseCO functionality is limited to adult patients. The intended environment for use is the hospital including Critical Care Units (such as Medical, Surgical, and Coronary), Trauma and Accident Emergency Units, Post Anesthesia Care Units, Operating Rooms, and Cardiac Catheterization labs. The Cogent™ HMS is intended to be used by trained and qualified individuals in medical and surgical intensive care units, operating rooms, trauma and accident emergency units, coronary and intensive care units and cardiac catheterization laboratories. The CogentTM HMS is restricted to one patient at a time.
    Device Description
    The Cogent™ HMS system is designed to compute and display cardiac and oximetry parameters relevant to patient care in the hospital acute care areas including Intensive Care Units and the Operating Room. Parameters include cardiac output and blood oxygen saturation levels, as well as other derived hemodynamic parameters. Measurements are obtained through ICU Medical pulmonary artery and central venous oximetry catheters, and ICU Medical CardioFloTM sensors. Input data for derived parameters may be keyed in by a clinician or may be obtained from a bedside monitor. The Cogent™ HMS provides the following functions: monitors patient cardiac output continuously, using continuous thermodilution, and intermittently, using bolus thermodilution; monitors cardiac output continuously using Pulse Power analysis on an arterial pressure waveform; monitors venous oxygen saturation by measuring the reflectance spectrum of the blood; and provides a general-purpose interface to the analog input/output channels of other monitoring devices. The Cogent" HMS consists of a base unit (patient interface module, PIM), a dedicated touch-screen display unit (user interface module, UIM) which allows for patient monitoring remotely (up to 50 feet), and the associated cables. The modules communicate with each other in docked, tethered (wired) or wireless mode. A physically separate optical module (OpMod) connects with an oximetry catheter. The Cogent™ HMS is designed for compatibility with PA catheters via connection to existing patient cables, i.e. unchanged cables as supplied with the primary predicate Q2 Plus. For the purpose of PulseCO™ data acquisition, the Cogent™ HMS is designed for compatibility with the CardioFloTM sensor and the new CardioFloTM reusable cable. In order to calculate blood oxygen saturation, the Cogent™ HMS is designed for compatibility with the existing optical module, its existing integrated cable and its associated compatible PA and oximetry catheters.
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    K Number
    K151969
    Device Name
    Hospira Extension Sets
    Manufacturer
    ICU Medical Inc
    Date Cleared
    2016-01-19

    (187 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICU Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
    Device Description
    The Hospira Extension Sets are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, flow control device, in-line adapter, injection site assembly, and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Extension sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.
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    K Number
    K131549
    Device Name
    CHEMOLOCK, CHEMOLOCK PORT
    Manufacturer
    ICU MEDICAL INC
    Date Cleared
    2013-07-26

    (58 days)

    Product Code
    ONB, FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICU MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
    Device Description
    The ChemoLock is a needlefree, single-use, Closed System Drug Transfer Device (CSTD). The ChemoLock has a mechanical means to prevent the transfer of environmental contaminants into the system, and the escape of drug or vapor concentrations outside the system. The system includes closed vial and bag access devices, a closed syringe adapter and closed patient administration sets. All components of the system include passive self-sealing mechanisms which cannot be deactivated and remain protective through disposal.
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    K Number
    K081361
    Device Name
    CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
    Manufacturer
    ICU MEDICAL INC
    Date Cleared
    2008-08-28

    (105 days)

    Product Code
    FPA, LHI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICU MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE®, Spikes, SPIROS™, GENIE™, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.
    Device Description
    The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is a combination of ICU Medical's products and tested for compatibility with lipids and/or cytotoxic agents. The "System" part is where these devices are packaged individually or sold together as a custom set upon order of the physician for the purpose of enabling the user a safe and inexpensive alternative to other passively closed systems.
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    K Number
    K052594
    Device Name
    WILLCARE, MODEL GW-1020
    Manufacturer
    ICU MEDICAL INC
    Date Cleared
    2006-02-10

    (142 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICU MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WillCare GX-1020 external pump is indicated for intravenous and non-intravenous infusion of medicinal products at set and variable rates.
    Device Description
    The WillCare GW-1020 is an electromechanical infusion pump designed for use with therapies requiring accurate delivery of small volumes of medication. The pump delivers fluid with a resolution of 0.002 milliliters and allows for continuous delivery, for intermittent delivery, or for a combination of both. Components of the pump that are essential for effective operation are listed in the operators manual (Components - Basic Kit), and must ONLY be supplied by ICU to ensure proper and safe operation.
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    K Number
    K041410
    Device Name
    PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
    Manufacturer
    ICU MEDICAL INC
    Date Cleared
    2004-07-28

    (62 days)

    Product Code
    FPA, FMI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICU MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to inject fluids into, or withdraw fluids from, parts of body below the surface of the skin.
    Device Description
    The PUNTUR-GUARD protects the health care worker from accidental needlestick by providing a blunting that renders safe the needle once it has entered the patient's vein. The PUNCTUR-GUARD is intended to enhance current safety needle programs
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