- Physicians Office Resource

BiPAP Pro BiFlex with Humidifier System One 60 Series, China
BiPAP System One 60 Series - BiPAP Pro Bi-Flex w/ Humid, System One 60 Series, CN

Device Description

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 bi-level positive airway pressure (BPAP) during spontaneous respiration for adult/child (non-infant) patients affected by obstructive sleep apnoea (OSA) and/or to treat patients with conditions requiring respiratory assistance in the home [e.g., chronic obstructive pulmonary disease (COPD)]. It is a small desktop unit with controls, and may include a built-in humidifier. The device is intended for use in the home but may also be used in healthcare facilities.

Environmental Conditions

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
15.00

Storage Environment Temperature - Degrees Celsius

60.00
-20.00

Storage Environment Temperature - Degrees Fahrenheit

140.00
-4.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00606959014312

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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