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Plum 360™ Infusion System with Hospira MedNet™ is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

The Plum 360TM Infusion System withMedNet / Smart Card Plug 'n' Play Module remains a volumetric Infusion System intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Dedicated administration sets are used for delivery of infusion therapy to the patient. The device has a user interface consisting of LCD display, front panel alphanumeric keypads and keys, audible and visual indicators, audible indicator volume control, nurse call interface, network interface connectors, the drug library and software that provides pre-defined display screens for therapy programming. The continued use of the MedNet Software allows communication between the Infusion Pump, MedNet server and the facility's communication systems.

Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system. Hospira Primary sets are indicated for the delivery of fluids from a container to a patient's vascular system.

The Hospira Extension Sets and the Hospira Primary 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, , in-line adapter, injection site assembly, and Dial-A-Flo. Hospira Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with a spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, Dial-A-Flo assembly and tubing. Extension sets and Primary Sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.

Hospira Sapphire Sets are indicated for the delivery of fluids from a container to a patient's vascular system.

Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. Hospira Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, in-line adapter, injection site assembly, check valve, and burette chamber. Hospira Sapphire sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.

Hospira Administration Sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira Administration sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use. Hospira Administration sets are intended for the delivery of fluids, including blood and blood products where indicated, from a container to a patient's vascular system.

The subject of this Special 510(k): Device Modification is the addition of an alternate luer activated needleless valve to existing Hospira Administration sets cleared under the identified predicate 510(k)s. Hospira Administration Sets are comprised of components in various combinations of the following: male luer adapter with cap, female luer with cap, piercing pin connector, tubing, flow control device, filter, in-line adapter, injection site assembly, luer activated needleless valve Nuitiv™ Connector, check valve, burette chamber, and blood chamber.

The LifeCare PCA™ infusion system is intended for intravenous or epidural administration of analgesic medications that are delivered by a continuous rate of infusion and/or with patient-controlled demand doses.

The Hospira LifeCare PCA™ Infusion System is a microprocessor controlled, pole mounted, electromechanical infusion pump that allows a patient to self-administer analgesic using an attached patient pendant, within physician prescribed, programmed parameters. The Hospira LifeCare PCA™ Infusion System also includes a sterile empty vial that can be pharmacy-filled with appropriate medications, and dedicated administration sets to administer the medication. The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser will accept either a pre-filled drug vial manufactured by Hospira or a sterile empty vial that can be filled by a hospital's pharmacy. Administration Sets compatible for use in the LifeCare PCA™ Infuser are provided sterile (fluid path) and intended for single-use application. The infuser is equipped with wireless (802.11 a/b/g) and wired interfaces to Hospira MedNet™ Software. Drug Libraries and Auto-Programs are transferred using these interfaces. The subject device bi-directionally communicates to the hospital information system through the Hospira MedNet™ Server, which is optional software, and the device can also be programmed and used without the Hospira MedNet™ software.

Hospira Blood sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.

The Hospira Blood Sets with Secure Lock are intended for use as gravity sets. Hospira Blood sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly / blood pump assembly / or blood cylinder assembly, and injection site assembly. Blood sets are configured to ensure the intended use of the device is met. Hospira Blood 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.

Hospira Primary sets are indicated for the delivery of fluids from a container to a patient's vascular system.

The Hospira Primary Sets with Secure Lock are intended for use as gravity sets. Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, dial-a-flo assembly and tubing. In addition to these components, a set may contain one or more of the following components: flow control device, drip chamber assembly and air inlet. Hospira Primary sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira infusion sets are disposable devices for single patient use.

Plum 360™ Infusion System with Hospira Mednet™ and Plum A+™ (360 Enabled™) Infusion System are indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood products.

The Plum 360TM Infusion System with Hospira MedNet™ remains a volumentric Infusion System intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Dedicated administration sets are used for delivery of infusion therapy to the patient. The device has a user interface consisting of LCD display, front panel numeric keypads and keys, audible and visual indicators, audible indicator volume control, nurse call interface, network interface connectors, the drug library, and software that provides pre-defined display screens for therapy programming. The continued use of the Hospira MedNet™ Software allows communication between the Infusion Pump, Hospira MedNet™ server and the facility's communication systems.

Hospira Burette sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.

The Hospira Burette Sets with Secure Lock are intended for use as gravity sets. Hospira Burette sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly and injection site assembly. Burette sets are configured to ensure the intended use of the device is met. Hospira Burette 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.

Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.

The Hospira Extension Sets with Secure Lock 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, stopcock and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Externsion 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.