EndoMask Essential® 300010

GUDID 00182151000839

Size #1, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high quality design as our silicone EndoMask Eclipse, but in a lower priced PVC model. It comprises a soft smooth cuff and a pliable tube body. The product is packaged in individual sterile pouches, 5 units per carton. Essential® 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 polymers are used in the manufacture of EndoMask® products. Manufacture of EndoMask Essential® 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, single-use
Primary Device ID00182151000839
NIH Device Record Key3582353c-5e2d-4e72-9fa3-7c732660d7b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoMask Essential®
Version Model NumberSize #1 - 300010
Catalog Number300010
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 Usetrue
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
GS100182151000839 [Primary]
GS100182151000853 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Product Code

CAEAirway, Oropharyngeal, Anesthesiology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-05-30

On-Brand Devices [EndoMask Essential® ]

00182151000846Size #5, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high quality
00182151000839Size #1, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high quality design
00182151000891Size #4, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high quality d
00182151000884Size #3, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high quality desi
00182151000877Size #2.5, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high quality d
10182151000720Size #2, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high quality de
00182151000860Size #1.5, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high quality des

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