Resusci Inflate-A-Shield CPR Barrier
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K001742 FDA 510(k)
- FDA Product Code
- CBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5870 FDA 510(k)
- Regulation Number
- 868.5870 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Resusci Inflate-A-Shield CPR Barrier is a Valve, Non-Rebreathing, designed to direct breathing gas flow to the patient while venting exhaled gases. It serves as a protective barrier during cardiopulmonary resuscitation (CPR) to prevent direct contact with the victim’s mouth, nose, and face, reducing the risk of exposure to bodily fluids and pathogens.
This single-use device is intended for use in emergency resuscitation settings, including pre-hospital and in-hospital environments. Supplied sterile and packaged individually, it adheres to FDA 510(k) clearance (K001742) under regulatory classification 868.5870. Compatible with standard CPR ventilation techniques, it is not intended for MRI use and must be discarded after a single use to maintain sterility and infection control standards.
Frequently asked questions
What is the primary purpose of the Resusci Inflate-A-Shield CPR Barrier in emergency resuscitation settings?
The Resusci Inflate-A-Shield CPR Barrier is designed as a non-rebreathing valve to direct breathing gas flow to the patient while safely venting exhaled gases. Its main function is to act as a protective barrier during CPR, preventing direct contact with the victim’s mouth, nose, and face. This reduces the risk of exposure to bodily fluids and pathogens, ensuring both rescuer and patient safety in emergency scenarios.
How is the Resusci Inflate-A-Shield CPR Barrier supplied, and what does this mean for infection control?
The device is supplied sterile and individually packaged, ensuring it is ready for immediate single-use. This packaging guarantees sterility and adheres to infection control standards, requiring the barrier to be discarded after one use to prevent cross-contamination.
Are there different sizes or models of the Resusci Inflate-A-Shield CPR Barrier, and how do I know which one to use?
The provided data lists multiple FEI numbers (e.g., 3005747797, 2020676), which typically correspond to different product variants or lot identifiers rather than distinct sizes or models. While exact sizing details are not specified, the barrier is designed for compatibility with standard CPR ventilation techniques, so it should fit most adult and pediatric resuscitation scenarios. Always verify compatibility with your specific resuscitation equipment and patient population.
Can the Resusci Inflate-A-Shield CPR Barrier be reused, and why is this important?
No, the device is intended for single-use only. Reuse is not recommended because it compromises sterility and infection control. The barrier is explicitly packaged sterile and must be discarded after one use to maintain safety standards, as outlined in the manufacturer’s instructions.
What storage conditions should be followed for the Resusci Inflate-A-Shield CPR Barrier?
While specific storage conditions aren’t detailed in the provided data, the device’s sterile, single-use packaging implies it should be stored in a clean, dry environment protected from contamination. Avoid exposure to extreme temperatures or moisture, and ensure the packaging remains intact until use to preserve sterility.
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: RESUSCI INFLATE-A-SHIELD CPR BARRIER - Innolitics, RESUSCI INFLATE-A-SHIELD CPR BARRIER by LAERDAL MEDICAL CORP. | FDA 510 ..., Laerdal® Face Shield products | Laerdal Medical, Laerdal Face Shield CPR Barrier - Laerdal Medical, RESUSCI INFLATE-A-SHIELD CPR BARRIER - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001742 | Class II | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical Corp.
Sources (1)
- FDA 510(k) K001742 24 fields · synced Sep 19, 2026