Laerdal Paediatric Pocket Mask, Model 820050
by Laerdal Medical A/S EUDAMED510(k)
Active
510(k) K023805
Overview
The Laerdal Paediatric Pocket Mask, Model 820050, is a non-rebreathing valve designed for use in paediatric resuscitation. It facilitates the delivery of oxygen or ventilatory support to infants and children by preventing exhaled gases from being inhaled by the patient, ensuring efficient gas exchange during resuscitation efforts.
This single-use device is intended for use in clinical settings such as emergency rooms, pre-hospital care, and operating rooms. Supplied sterile in a sealed package, it adheres to FDA 510(k) and MDR regulatory standards. The mask is classified as a Class II medical device and is intended for one-time use only, with no reuse or reprocessing recommended. Its design ensures compatibility with standard resuscitation equipment and adheres to MRI safety guidelines for non-ferromagnetic materials.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK023805 | Date11 Feb 2003 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CBP
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5870
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Laerdal Medical A/S
Questions
What clinical settings is the Laerdal Paediatric Pocket Mask, Model 820050, intended for use in and why?
The Laerdal Paediatric Pocket Mask, Model 820050, is designed for use in clinical settings such as emergency rooms, pre-hospital care, and operating rooms. This is because it is specifically engineered to facilitate oxygen delivery or ventilatory support during paediatric resuscitation, ensuring efficient gas exchange by preventing exhaled gases from being re-inhaled by the patient.
Is the Laerdal Paediatric Pocket Mask, Model 820050, reusable or single-use, and how should it be handled to maintain sterility?
The Laerdal Paediatric Pocket Mask, Model 820050, is a single-use device and is not intended for reuse or reprocessing. It is supplied sterile in a sealed package, so it should remain unopened until immediate use. Once opened, it should be used only once and then discarded to maintain sterility and ensure patient safety.
What regulatory standards does the Laerdal Paediatric Pocket Mask, Model 820050, comply with, and how does this affect its use?
The Laerdal Paediatric Pocket Mask, Model 820050, complies with both FDA 510(k) and MDR (Medical Device Regulation) standards, confirming its safety and performance for clinical use. This regulatory compliance ensures that the device meets stringent quality and efficacy requirements, making it suitable for use in paediatric resuscitation across various healthcare environments.
Can the Laerdal Paediatric Pocket Mask, Model 820050, be used in MRI environments, and why?
Yes, the Laerdal Paediatric Pocket Mask, Model 820050, is designed to adhere to MRI safety guidelines for non-ferromagnetic materials. This means it can be safely used in MRI environments without interfering with the imaging process or posing risks to patients.
What sizes or models of the Laerdal Paediatric Pocket Mask, Model 820050, are available, and how do I know which one to choose for a patient?
The provided data does not specify multiple sizes or models beyond the single model number 820050. Since it is designed for paediatric use, it is likely sized to accommodate infants and children. For precise sizing, refer to the manufacturer’s instructions or consult clinical guidelines, as the correct fit is critical for effective resuscitation. The device is universally compatible with standard resuscitation equipment, ensuring ease of use across different clinical scenarios.