EndoMask Elite®

Primary DI
10182151000690
Brand
EndoMask Elite®
Company
MERLYN ASSOCIATES, INC.
Model
Size #1 - 280010
Catalog number
280010
Device description
Size #1, 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.
Published
2017-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00182151000693PackageGS15In Commercial Distribution
10182151000690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00182151000693001821510006931821510006930182151000693
1018215100069010182151000690

GMDN Terms#

Term, Definition table
TermDefinition
Oropharyngeal airway, reusableA curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
606864184
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00182151000037Merlyn EndoTubeOral/Nasal 4010354010352016-06-01
00182151000044Merlyn EndoTubeOral/Nasal 4010404010402016-06-01
00182151000051Merlyn EndoTubeOral/Nasal 4010454010452016-06-01
00182151000068Merlyn EndoTubeOral/Nasal 4010504010502016-06-01
00182151000075Merlyn EndoTubeOral/Nasal 4010554010552016-06-01
00182151000082Merlyn EndoTube Oral/Nasal 4010604010602016-06-01
00182151000099Merlyn EndoTubeOral/Nasal 4010654010652016-06-01
00182151000105Merlyn EndoTubeOral/Nasal 4010704010702016-06-01
00182151000112Merlyn EndoTubeOral/Nasal 4010754010752016-06-01
00182151000129Merlyn EndoTubeOral/Nasal 4010804010802016-06-01
00182151000136Merlyn EndoTubeOral/Nasal 4010854010852016-06-01
00182151000143Merlyn EndoTubeOral/Nasal 4110304110302016-06-01
00182151000150Merlyn EndoTubeOral/Nasal 4110354110352016-06-01
00182151000167Merlyn EndoTubeOral/Nasal 4110404110402016-06-01
00182151000174Merlyn EndoTubeOral/Nasal 4110454110452016-06-01
00182151000181Merlyn EndoTubePreformed Oral 4200404200402016-06-01
00182151000198Merlyn EndoTubePreformed Oral 4200454200452016-06-01
00182151000204Merlyn EndoTubePreformed Oral 4200504200502016-06-01
00182151000211Merlyn EndoTubePreformed Oral 4200554200552016-06-01
00182151000228Merlyn EndoTubePreformed Oral 4200604200602016-06-01

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