AUTOSET SPIRIT FILTER 1PK

AUTOSET SPIRIT FILTER 1PK
AUTOSET - 30919

A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.

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: 00619498309191

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: 00619498309085

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00619498309191

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 00619498309078

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00619498309191

Package Quantity: 3

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A