- Physicians Office Resource

Evolve Bunnell Life Pulse Conv Pack with Natvar
INOmax - 50383

Device Description

A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.

Environmental Conditions

Storage Environment Atmospheric Pressure - KiloPascal

110.00
57.00

Storage Environment Humidity - millibar

95.00
15.00

Storage Environment Temperature - Degrees Celsius

60.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: BZO

Device Name: Set, Tubing And Support, Ventilator (W Harness)

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: 868.5975

Third Party Flag: N

Medical Specialty: AN

Device Identifiers

Device Id: 10810055280114

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00810055280117

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 00810055280117

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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