Portex

Portex - 8518

A screening device intended to be installed in a reusable gas sampling line or gas measuring instrument to remove and retain bacterial pathogens, and sometimes moisture, from the gas. It is designed to prevent a measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, bedside respiration monitor] and the system it is connected to (e.g., a breathing circuit) from becoming contaminated to reduce the risk of patient cross-contamination. Some types function as a water trap to help minimize damage to the measuring instrument from gas condensation. This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NHK

Device Name: Resuscitator, Manual, Non Self-Inflating

Device Class: 2

Physical State: N/A

Definition: A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5905

Third Party Flag: N

Medical Specialty: AN

Device Id: 30351688431541

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10351688431547

Package Quantity: 40

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX

Device Id: 10351688431547

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