EndoMask Eclipse®
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Basic Information
- Brand Name
- EndoMask Eclipse®
- Primary DI
- 00182151000778
- Version / Model
- Size #1.5 - 291015
- Catalog Number
- 291015
- Company Name
- MERLYN ASSOCIATES, INC.
- Labeler DUNS
- 606864184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-30
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 863fccab-bc37-4a19-8131-d4e980116002
Device Description
Size #1.5, 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | 868.5110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42424 | Oropharyngeal airway, single-use | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10182151000775 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00182151000778 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 120 Degrees Fahrenheit