- Physicians Office Resource

Adult Electrostatic Filter HME with Catheter Mount Large
DAR - 352/5811

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

Special Storage Condition, Specify

Fragile, Keep dry, This side up

Device Sizes

Tidal Volume, 300-1500, ML;

Tidal Volume, 300-1500, ML;

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: CAH

Device Name: Filter, Bacterial, Breathing-Circuit

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

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: 868.5260

Third Party Flag: Y

Medical Specialty: AN

Device Identifiers

Device Id: 10884522038508

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884522038505

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 20884522038505

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

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