Shell with Velcro Patch Assembly,For Soft Headgear CPAP Interface Circuit


Product Overview

Shell with Velcro Patch Assembly,For Soft Headgear CPAP Interface Circuit
Puritan Bennett - S-231700-00B


Device Description

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose 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. 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.


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: BYG

Device Name: Mask, Oxygen

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 868.5580

Third Party Flag: N

Medical Specialty: AN


Device Identifiers

Device Id: 10884521134386

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521134383

Package Quantity: 500

Package Discontinue Date: 2/21/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CASE


Device Id: 20884521134383

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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