Duns Number:606864184
Device Description: Size #1, Single-use PVC Laryngeal Mask EndoMask Essential® offers the same high quality de 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.
Catalog Number
300010
Brand Name
EndoMask Essential®
Version/Model Number
Size #1 - 300010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAE
Product Code Name
Airway, Oropharyngeal, Anesthesiology
Public Device Record Key
3582353c-5e2d-4e72-9fa3-7c732660d7b3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 30, 2017
Package DI Number
00182151000853
Quantity per Package
5
Contains DI Package
00182151000839
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |