Portex - 20-0050
Device Description
A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.
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: BWF
Device Name: Spirometer, Therapeutic (Incentive)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
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: 868.5690
Third Party Flag: Y
Medical Specialty: AN
Device IdentifiersDevice Id: 50788942200508
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10788942200500
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 10788942200500
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