GECKO NASAL PAD LGE - AMER

GECKO NASAL PAD LGE
GECKO NASAL PAD LGE - AMER - 61910

A 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 and/or 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 reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FMP

Device Name: Protector, Skin Pressure

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.6450

Third Party Flag: N

Medical Specialty: HO

Device Id: 00619498619108

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

Device Id: 00619498619153

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00619498619108

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX