EndoMask Eclipse® 291010

GUDID 00182151000761

Size #1, 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.

MERLYN ASSOCIATES, INC.

Oropharyngeal airway, single-use
Primary Device ID00182151000761
NIH Device Record Keyb625495d-6dc2-4d25-b97b-89d7857a0b67
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoMask Eclipse®
Version Model NumberSize #1 - 291010
Catalog Number291010
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
GS100182151000761 [Primary]

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 Number3
Public Version Date2018-11-01
Device Publish Date2017-05-30

On-Brand Devices [EndoMask Eclipse® ]

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00182151000785Size #2, Single-use Silicone Laryngeal Mask EndoMask Eclipse® offers the same high quality d
10182151000775Size #1.5, Single-use Silicone Laryngeal Mask EndoMask Eclipse® offers the same high quality de
00182151000761Size #1, Single-use Silicone Laryngeal Mask EndoMask Eclipse® offers the same high quality d
10182151000645Size #5, Single-use Silicone Laryngeal Mask EndoMask Eclipse® offers the same high
10182151000638Size #4, Single-use Silicone Laryngeal Mask EndoMask Eclipse® offers the same high
00182151000624Size #3, Single-use Silicone Laryngeal Mask EndoMask Eclipse® offers the same high quality desi

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