EndoMask Elite® - Size #1.5, Silicone Reusable (50 times) Laryngeal - MERLYN ASSOCIATES, INC.

Duns Number:606864184

Device Description: Size #1.5, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality Size #1.5, 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.

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More Product Details

Catalog Number

280015

Brand Name

EndoMask Elite®

Version/Model Number

Size #1.5 - 280015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Device Record Status

Public Device Record Key

c1f3687f-d51a-41f3-be8c-d0435ec0219e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 30, 2017

Additional Identifiers

Package DI Number

10182151000683

Quantity per Package

5

Contains DI Package

00182151000686

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MERLYN ASSOCIATES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 54