Adult
DAR - 353U5413
Device Description
A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.
Environmental Conditions
- Fragile, Keep dry, This side up
Device Sizes
- Tidal Volume, 100-1000, ML;
Device Sterilization
Device Sterile: False
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: 30884522011864
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20884522011867
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 20884522011867
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