EndoMask Elite® 280040

GUDID 00182151000013

Size #4, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality reusable silicone laryngeal mask that may be cleaned and sterilized for up to 50 uses. Elite® comprises a soft smooth cuff and a soft, pliable tube body. The product is packaged in individual sterile pouches, 5 units per carton. Each Elite® mask is uniquely numbered and comes with a tracking card with that same unique number for easy tracking of each use and re-use after cleaning and sterilization by steam autoclave process. Elite® 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 medical grade silicone polymers are used in the manufacture of EndoMask® products. Manufacture of EndoMask Elite® is under the strictest quality control and sterile conditions. All EndoMask® products utilize 100 percent latex free manufacturing and packaging materials.

MERLYN ASSOCIATES, INC.

Oropharyngeal airway, reusable

• Primary Device ID: 00182151000013
• NIH Device Record Key: d319da99-148b-46e5-9da2-0ed06ea6e794
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoMask Elite®
• Version Model Number: Size #4 - 280040
• Catalog Number: 280040
• Company DUNS: 606864184
• Company Name: MERLYN ASSOCIATES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00182151000013 [Primary]
GS1	10182151000010 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• CAE: Airway, Oropharyngeal, Anesthesiology

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00182151000013]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-01
• Device Publish Date: 2017-05-30

On-Brand Devices [EndoMask Elite® ]

• 10182151000683: Size #1.5, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality reu
• 00182151000679: Size #2, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality reusa
• 10182151000669: Size #2.5, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quali
• 10182151000652: Size #3, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality reusa
• 00182151000013: Size #4, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality re
• 10182151000003: Size #5, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality reusa