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 IdentifiersDevice Id: 04953170438271
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