NRFit - 21-7600-24
Device Description
A sterile device designed to be used in conjunction with an infusion pump or a device containing an infusion pump (e.g., a physiology-monitoring sedation system, physiology-monitoring anaesthesia system), for the delivery of an intravenous (IV) medication (e.g., a sedative or anaesthetic) contained within an independent drug vial. The cassette is inserted into the infusion pump and the drug vial is inserted into the cassette; the cassette tubing interfaces with the pump drive mechanism for medication delivery through connection with an infusion administration set. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PWH
Device Name: Administrations Sets With Neuraxial Connectors
Device Class: 2
Physical State: The connector consists of a ISO 80369-6 compliant connection and may be composed of plastic.
Definition: The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The neuraxial connector is attached to a small bore connector intended to be used for neuraxial applications and intended to facilitate in administration of medication or act as a transitional piece to be used with administration sets with a non ISO 80369-6 compliant connection.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: The neuraxial space
Regulation Number: 880.5440
Third Party Flag: N
Medical Specialty: HO
Code: LHI
Device Name: Set, I.V. Fluid Transfer
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
Device IdentifiersDevice Id: 30610586044001
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10610586044007
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 10610586044007
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
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