Portex - 55-4700
Device Description
An electrically-powered electronic instrument designed to measure and establish the degree of positive or negative pressure (pneumatic or hydraulic) found in a medical device, piece of equipment, or system. It is connected to the device, equipment, or system with the unknown pressure via a hose or connector and the pressure is sensed by this device and converted into a digital pressure reading displayed in one of several units, e.g., mmHg, cmH2O, or pascal. It is typically used by a healthcare provider (i.e., clinical technician) in a clinical setting.
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: BXR
Device Name: Meter, Airway Pressure (Inspiratory Force)
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: 868.1780
Third Party Flag: Y
Medical Specialty: AN
Device IdentifiersDevice Id: 10788942547001
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