Medex

Medex - MX837E

A collection of non-powered devices designed to be used and interact with a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of a high pressure line, a high pressure stopcock, and a hand-held manual controller used to stop and start the contrast medium injection system instantaneously. It is typically made of plastic materials and may have one control for dispensing the contrast medium and a second for dispensing the saline. This is a single-use device.

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Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: FPB

Device Name: Filter, Infusion Line

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: 50351688504744

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10351688504746

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10351688504746

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