Product Overview

GAS FILTER - MAJ-822


Device Description

A component of a medical gas pipeline system designed as an exchangeable filter to trap the impurities of the air that is being produced by, e.g., a hospital's compressors, and that passes through it. It is composed of tightly woven materials through which the air passes and particles/impurities are trapped in the filter material removing these from the air producing clean, filtered air to meet the specified requirement. For medical air, several filters may be used in-line. After application, this device cannot be reused.


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: FEB

Device Name: Accessories, Cleaning, For Endoscope

Device Class: 2

Physical State: N/A

Definition: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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: 876.1500

Third Party Flag: N

Medical Specialty: GU


Device Identifiers

Device Id: 04953170069468

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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