AF541 Under the Nose Mask with Entrainment Elbow, Leak 1, with Capstrap, Size A, Japan

AF541 Under the Nose Mask with Entrainment Elbow, Leak 1, with Capstrap, Size A, Japan
AF541 - AF541 Mask EE, Leak 1, Under the Nose, Capstrap, Size A, JP

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: BZD

Device Name: Ventilator, Non-Continuous (Respirator)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 868.5905

Third Party Flag: N

Medical Specialty: AN

Device Id: 30606959041227

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00606959041226

Package Quantity: 10

Package Discontinue Date: 2/28/2021 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Multipack

Device Id: 00606959041226

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