PharmGuard

PharmGuard - 22-0004-0206-25

An application software program designed as an Internet-based information system intended to replace paper forms by electronically collecting and recording all types of patient clinical information, investigation results, and treatment data. It is a generic system which can be used in healthcare by configuration of workflows, metadata, and data lifecycles; and by integration into electronic medical record (EMR) systems using standard protocols. The electronic forms are intended to provide predefined workflow, input, search, and display functionalities, typically to manage a particular treatment or condition [e.g., hyposensitization (allergy desensitization), cleft lip].

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PHC

Device Name: Infusion Safety Management Software

Device Class: 2

Physical State: The device is a software application(s), which may be implemented as part of an infusion pump and may also be implemented onto a hospital information system for use with an infusion pump system.

Definition: Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Infusion safety management software may include one or more software applications that enforce safety control mechanisms through wireless or wired communication between the hospital information system, the infusion pump, and the healthcare provider.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Target area is according to the approved drug or biologic product labeling.

Regulation Number: 880.5725

Third Party Flag: N

Medical Specialty: HO

Device Id: 15019517225471

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A