INOmax DSIR Plus

INOmax DSIR Plus
INOmax DSIR Plus - 10007

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

Handling Environment Atmospheric Pressure - KiloPascal

110.00
57.00

Handling Environment Humidity - Percent (%) Relative Humidity

95.00
15.00

Handling Environment Temperature - Degrees Celsius

40.00
5.00

Special Storage Condition, Specify

Could be "Do not subject to sunlight" or "transport only in closed trucks" etc.

Storage Environment Atmospheric Pressure - KiloPascal

110.00
57.00

Storage Environment Humidity - Percent (%) Relative Humidity

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: MRQ

Device Name: Analyzer, Nitrogen Dioxide

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: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.2385

Third Party Flag: Y

Medical Specialty: AN

Code: MRO

Device Name: Apparatus, Nitric Oxide, Backup Delivery

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: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5165

Third Party Flag: N

Medical Specialty: AN

Code: MRP

Device Name: Analyzer, Nitric Oxide

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: 868.2380

Third Party Flag: N

Medical Specialty: AN

Code: MRN

Device Name: Apparatus, Nitric Oxide Delivery

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: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5165

Third Party Flag: N

Medical Specialty: AN

Device Identifiers

Device Id: 00867538000106

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