MERLYN ASSOCIATES, INC.

Address:2850 South Harbor Blvd.,Santa Ana,CA,92704,US

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- Catalog Number : 280050

Device Description : Size #5, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high Size #5, 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.

Device Class : 1

Duns Number: 606864184

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 280040

Device Description : Size #4, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our h Size #4, 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.

Device Class :

Duns Number: 606864184

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 401030

Device Description : 3.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiop 3.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip

Device Class :

Duns Number: 606864184

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 401035

Device Description : 3.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiop 3.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip

Device Class : 2

Duns Number: 606864184

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 401040

Device Description : 4.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiop 4.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip

Device Class : 2

Duns Number: 606864184

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 401045

Device Description : 4.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiop 4.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip

Device Class : 2

Duns Number: 606864184

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 401050

Device Description : 5.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiop 5.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip

Device Class : 2

Duns Number: 606864184

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 401055

Device Description : 5.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiop 5.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip

Device Class : 2

Duns Number: 606864184

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 401060

Device Description : 6.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiop 6.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip

Device Class : 2

Duns Number: 606864184

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

- Catalog Number : 401065

Device Description : 6.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiop 6.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip

Device Class : 2

Duns Number: 606864184

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1