EndoMask Eclipse®
MERLYN ASSOCIATES, INC. · Model Size #2 - 291020 · UDI-DI 00182151000785
Description
Size #2, Single-use Silicone Laryngeal Mask EndoMask Eclipse® offers the same high quality design and the same silicone materials as reusable EndoMask Elite® in a single-use disposable model. It comprises a soft smooth cuff and a soft to medium rigid tube body. The product is packaged in individual sterile pouches, 5 units per carton. Eclipse® has a superior inflatable cuff that conforms to the natural contours of the hypopharynx for perfect fit. Our cuff and tube assembly enables rapid, blind insertion, excellent seal, and single-hand ventilation. The seam around the outside of the inflatable cuff is smooth while the seam of most competitors is often rough and can cause irritation. Our cuff assembly and tube body is smoother and has less voids and impurities within its structure then other silicone laryngeal masks. There are no epiglottic bar (aperture bar) obstructions enabling easy access for a fiberscope and suction catheters. Only premium medical grade silicone is used in the manufacture of EndoMask® products. Manufacture of EndoMask Eclipse® is under the strictest quality control and sterile conditions. All EndoMask® products utilize 100 percent latex free manufacturing and packaging materials.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-07 | INTEGRATED MEDCRAFT LLC | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. |
| 2026-06-15 | Intersurgical Inc | Devices could potentially be occluded or partially occluded. |
| 2026-06-15 | Intersurgical Inc | Devices could potentially be occluded or partially occluded. |
| 2025-06-20 | Intersurgical Inc | Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and inf |
| 2025-06-20 | Intersurgical Inc | Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and inf |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
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