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EndoMask Essential®

FDA UDI

Class I (US FDA UDI)

by Merlyn Associates, Inc.

Identity

Trade Name
EndoMask Essential® FDA UDI
Generic Name
Oropharyngeal airway, single-use FDA UDI
Device Name
Size #5, 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. FDA UDI
Model / Reference
Size #5 - 300050 FDA UDI
Description
Size #5, 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. FDA UDI

Identifiers

Catalog Number
300050 FDA UDI
Primary DI / UDI-DI
00182151000846 FDA UDI
FDA Product Code
CAE FDA UDI
GMDN Term
Oropharyngeal airway, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5110 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Oropharyngeal airway, single-use

EndoMask Essential® by Merlyn Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oropharyngeal airway, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merlyn Associates, Inc.

Sources (1)

  • FDA UDI a53a98e8-00f6-4cd6-a453-42b978af49e2 35 fields · synced May 30, 2026