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 ID00182151000013
NIH Device Record Keyd319da99-148b-46e5-9da2-0ed06ea6e794
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoMask Elite®
Version Model NumberSize #4 - 280040
Catalog Number280040
Company DUNS606864184
Company NameMERLYN ASSOCIATES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100182151000013 [Primary]
GS110182151000010 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Product Code

CAEAirway, Oropharyngeal, Anesthesiology

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00182151000013]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-01
Device Publish Date2017-05-30

On-Brand Devices [EndoMask Elite® ]

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

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