MASK, PEDIATRIC FACE WITH EARLOOP

MASK, PEDIATRIC FACE WITH EARLOOP
McKesson - 16-1000

A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FXX

Device Name: Mask, Surgical

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: 878.4040

Third Party Flag: Y

Medical Specialty: SU

Code: OXZ

Device Name: Pediatric/Child Facemask

Device Class: 2

Physical State: A pediatric/child facemask is constructed of nonwoven materials. A nosepiece is placed within the bindings for comfort and individualized fit. It is appropriately sized to the smaller faces of children across a diverse population. It is intended to be worn by the patient/child and is a single use, disposable device. It is intended to be worn by the pediatric patient to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials.

Definition: A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Anthrophometric data requirement

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Respiratory Tract

Regulation Number: 878.4040

Third Party Flag: N

Medical Specialty: SU

Device Id: 40612479230895

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20612479230884

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 20612479230884

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10612479230870

Package Quantity: 75

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 10612479230870

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