Airlife Infant Nasal Continuous Positive Airway Pressure System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050994 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Airlife Infant Nasal Continuous Positive Airway Pressure System is a non-continuous ventilator designed to deliver an air and oxygen mixture to provide continuous positive airway pressure. The system consists of a generator, prongs, masks, and a headgear fixation device to support infants with compromised respiratory systems.
This device is intended for use in hospital environments and is operated by clinical staff. It connects to an external driver via a circuit to maintain prescribed pressure levels. All materials used in the fabrication of the system have been evaluated through biological qualification safety tests in accordance with ISO 10993 Part-1.
Frequently asked questions
What is the primary purpose of the Airlife Infant Nasal CPAP System?
This system is designed to provide continuous positive airway pressure to infants with compromised respiratory systems by delivering a controlled mixture of air and oxygen.
In what environment is this device intended to be used?
The system is intended for use exclusively within hospital environments and must be operated by trained clinical staff to ensure proper management of respiratory support.
How does the system connect to provide pressure support?
The device connects to an external driver via a circuit, which allows clinical staff to maintain the prescribed pressure levels required for the patient's respiratory care.
What components are included in the system?
The system is comprised of a generator, nasal prongs, masks, and a headgear fixation device, all of which work together to support the infant's respiratory needs.
Have the materials used in this system been safety tested?
Yes, all materials used in the fabrication of the Airlife Infant Nasal CPAP System have been evaluated through biological qualification safety tests in accordance with ISO 10993 Part-1.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Airlife Infant Nasal Continuous Positive Airway Pressure System ..., PDF CardinalHealth - Manuals+, PDF CardinalHealth - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050994 | Class II | Active |
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Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA 510(k) K050994 24 fields · synced Sep 26, 2026