PharmGuard - 21-2194-0403-25
Device Description
A software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MEA
Device Name: Pump, Infusion, Pca
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.5725
Third Party Flag: N
Medical Specialty: HO
Code: FPA
Device Name: Set, Administration, Intravascular
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.5440
Third Party Flag: Y
Medical Specialty: HO
Code: PYR
Device Name: Neuraxial Administration Set - Intrathecal Delivery
Device Class: 2
Physical State: Administration sets are made of polymers and connected to infusion pumps or medication containers such as syringes or flexible medication containers.
Definition: Neuraxial Administration Sets used to deliver fluids to the intrathecal space.
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Administration sets are made of polymers, are connected to infusion pumps or medication containers (i.e. syringes, flexible medication containers), and are used to deliver fluids from the storage container or pump into the intrathecal space. These sets may include ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial connectors.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: intrathecal space
Regulation Number: 880.5440
Third Party Flag: N
Medical Specialty: HO
Code: MRZ
Device Name: Accessories, Pump, Infusion
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.5725
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 15019517197112
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