Adult Mechanical Filter HME with Catheter Mount Large
DAR - 354/5902
Device Description
A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Tidal Volume, 300-1500, ML;
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: BYD
Device Name: Condenser, Heat And Moisture (Artificial Nose)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 868.5375
Third Party Flag: N
Medical Specialty: AN
Device IdentifiersDevice Id: 10884522026758
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20884522026755
Package Quantity: 25
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 20884522026755
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