NRFit

NRFit - 21-7609-24

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.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 30610586044018

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10610586044014

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX

Device Id: 10610586044014

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