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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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EndoMask Elite® - 00182151000662

Size #2.5, 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.
MERLYN ASSOCIATES, INC.
Size #2.5 - 280025
In Commercial Distribution

  • 10182151000669 ()
  • 00182151000662 ()
280025

  • Oropharyngeal airway, reusable

EndoMask Elite® - 00182151000655

Size #3, 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.
MERLYN ASSOCIATES, INC.
Size #3 - 280030
In Commercial Distribution

  • 10182151000652 ()
  • 00182151000655 ()
280030

  • Oropharyngeal airway, reusable

EndoMask Eclipse® - 00182151000648

Size #5, 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.
Size #5 - 291050
In Commercial Distribution

  • 10182151000645 ()
  • 00182151000648 ()
291050

  • Oropharyngeal airway, single-use

EndoMask Eclipse® - 00182151000631

Size #4, 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.
Size #4 - 291040
In Commercial Distribution

  • 10182151000638 ()
  • 00182151000631 ()
291040

  • Oropharyngeal airway, single-use

EndoMask Eclipse® - 00182151000624

Size #3, 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.
Size #3 – 291030
In Commercial Distribution

  • 00182151000624 ()
  • 10182151000621 ()
291030

  • Oropharyngeal airway, single-use

EndoMask Elite® - 00182151000013

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.
MERLYN ASSOCIATES, INC.
Size #4 - 280040
In Commercial Distribution

  • 00182151000013 ()
  • 10182151000010 ()
280040

  • Oropharyngeal airway, reusable

EndoMask Elite® - 00182151000006

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.
MERLYN ASSOCIATES, INC.
Size #5 - 280050
In Commercial Distribution

  • 10182151000003 ()
  • 00182151000006 ()
280050

  • Oropharyngeal airway, reusable

MedSource Berman Airways - 00840155404380

Berman Colored Airways Kit
MEDSOURCE INTERNATIONAL LLC
MS-BAW
In Commercial Distribution

  • 00840155404380 ()
Not Applicable

  • Oropharyngeal airway, single-use

MedSource Airway Devices - 00840155411722

Paulsen Airway, 100mm
MEDSOURCE INTERNATIONAL LLC
MS-238100
In Commercial Distribution

  • 00840155411739 ()
  • 00840155411722 ()
  • 00840155411746 ()
Not Applicable

  • Oropharyngeal airway, single-use

ENDURE INDUSTRIES - 00840118607308

Berman Airway, #5 - 110 mm
ENDURE INDUSTRIES
OB112
In Commercial Distribution

  • 00840118607322 ()
  • 00840118607308 ()
OB112

  • Oropharyngeal airway, single-use

ENDURE INDUSTRIES - 00840118607292

Berman Airway, #4 - 100 mm
ENDURE INDUSTRIES
OB102
In Commercial Distribution

  • 00840118607315 ()
  • 00840118607292 ()
OB102

  • Oropharyngeal airway, single-use

ENDURE INDUSTRIES - 00840118607278

Berman Airway, #3 - 90 mm
ENDURE INDUSTRIES
OB92
In Commercial Distribution

  • 00840118607285 ()
  • 00840118607278 ()
OB92

  • Oropharyngeal airway, single-use

ENDURE INDUSTRIES - 00840118607254

Berman Airway, #2 - 80 mm
ENDURE INDUSTRIES
OB82
In Commercial Distribution

  • 00840118607261 ()
  • 00840118607254 ()
OB82

  • Oropharyngeal airway, single-use

ENDURE INDUSTRIES - 00840118607230

Berman Airway, #1 - 70 mm
ENDURE INDUSTRIES
OB72
In Commercial Distribution

  • 00840118607247 ()
  • 00840118607230 ()
OB72

  • Oropharyngeal airway, single-use

ENDURE INDUSTRIES - 00840118607216

Berman Airway, #0 - 60 mm
ENDURE INDUSTRIES
OB62
In Commercial Distribution

  • 00840118607223 ()
  • 00840118607216 ()
OB62

  • Oropharyngeal airway, single-use

ENDURE INDUSTRIES - 00840118607186

Berman Airway, #00 - 50 mm
ENDURE INDUSTRIES
OB52
In Commercial Distribution

  • 00840118607209 ()
  • 00840118607186 ()
OB52

  • Oropharyngeal airway, single-use

ENDURE INDUSTRIES - 00840118607179

Berman Airway, #000 - 40 mm
ENDURE INDUSTRIES
OB42
In Commercial Distribution

  • 00840118607193 ()
  • 00840118607179 ()
OB42

  • Oropharyngeal airway, single-use

SH 77-S Set of Oropharyngeal Airways - M996SH77S0

SH 77-S is a set of seven sizes of oropharyngeal airways ranging from 40mm to 100mm. Use of an Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-S
In Commercial Distribution

  • M996SH77S0 ()
SH 77-S

  • Oropharyngeal airway, single-use

SH 77-7 Oropharyngeal Airway - M996SH7770

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 100 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-7
In Commercial Distribution

  • M996SH7775 ()
  • M996SH7770 ()
  • M996SH7772 ()

  • Length: 90 Millimeter


  • Oropharyngeal airway, single-use

SH 77-6 Oropharyngeal Airway - M996SH7760

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 90 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-6
In Commercial Distribution

  • M996SH7765 ()
  • M996SH7760 ()
  • M996SH7762 ()

  • Length: 90 Millimeter


  • Oropharyngeal airway, single-use

SH 77-5 Oropharyngeal Airway - M996SH7750

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 80 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-5
In Commercial Distribution

  • M996SH7755 ()
  • M996SH7750 ()
  • M996SH7752 ()

  • Length: 80 Millimeter


  • Oropharyngeal airway, single-use

SH 77-4 Oropharyngeal Airway - M996SH7740

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 70 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-4
In Commercial Distribution

  • M996SH7745 ()
  • M996SH7740 ()
  • M996SH7742 ()

  • Length: 70 Millimeter


  • Oropharyngeal airway, single-use

SH 77-3 Oropharyngeal Airway - M996SH7730

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 60 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-3
In Commercial Distribution

  • M996SH7735 ()
  • M996SH7730 ()
  • M996SH7732 ()

  • Length: 60 Millimeter


  • Oropharyngeal airway, single-use

SH 77-2 Oropharyngeal Airway - M996SH7720

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 50 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-2
In Commercial Distribution

  • M996SH7725 ()
  • M996SH7720 ()
  • M996SH7722 ()

  • Length: 50 Millimeter


  • Oropharyngeal airway, single-use

SH 77-1 Oropharyngeal Airway - M996SH7710

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 40 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-1
In Commercial Distribution

  • M996SH7715 ()
  • M996SH7710 ()
  • M996SH7712 ()

  • Length: 40 Millimeter


  • Oropharyngeal airway, single-use

Berman Airways - 10641043800904

No Description
MERCURY ENTERPRISES, INC.
10-80090
In Commercial Distribution

  • 30641043800908 ()
  • 10641043800904 ()


  • Oropharyngeal airway, single-use

Berman Airways - 10641043800805

No Description
MERCURY ENTERPRISES, INC.
10-80080
In Commercial Distribution

  • 30641043800809 ()
  • 10641043800805 ()


  • Oropharyngeal airway, single-use

Berman Airways - 10641043800706

No Description
MERCURY ENTERPRISES, INC.
10-80070
In Commercial Distribution

  • 30641043800700 ()
  • 10641043800706 ()


  • Oropharyngeal airway, single-use

Berman Airways - 10641043800607

No Description
MERCURY ENTERPRISES, INC.
10-80060
In Commercial Distribution

  • 30641043800601 ()
  • 10641043800607 ()


  • Oropharyngeal airway, single-use

Berman Airways - 10641043800508

No Description
MERCURY ENTERPRISES, INC.
10-80050
In Commercial Distribution

  • 30641043800502 ()
  • 10641043800508 ()


  • Oropharyngeal airway, single-use

Berman Airways - 10641043800409

No Description
MERCURY ENTERPRISES, INC.
10-80040
In Commercial Distribution

  • 30641043800403 ()
  • 10641043800409 ()


  • Oropharyngeal airway, single-use

Berman Airways - 10641043800102

No Description
MERCURY ENTERPRISES, INC.
10-80010
In Commercial Distribution

  • 30641043800106 ()
  • 10641043800102 ()


  • Oropharyngeal airway, single-use

Berman Airways - 10641043800003

No Description
MERCURY ENTERPRISES, INC.
10-80000
In Commercial Distribution

  • 30641043800007 ()
  • 10641043800003 ()


  • Oropharyngeal airway, single-use

Guedel Airways (color coded) - 10641043816905

90MM
MERCURY ENTERPRISES, INC.
10-81690
In Commercial Distribution

  • 30641043816909 ()
  • 10641043816905 ()


  • Oropharyngeal airway, single-use

Guedel Airways (color coded) - 10641043816806

80MM
MERCURY ENTERPRISES, INC.
10-81680
In Commercial Distribution

  • 30641043816800 ()
  • 10641043816806 ()


  • Oropharyngeal airway, single-use

Guedel Airways (color coded) - 10641043816707

70MM
MERCURY ENTERPRISES, INC.
10-81670
In Commercial Distribution

  • 30641043816701 ()
  • 10641043816707 ()


  • Oropharyngeal airway, single-use

Guedel Airways (color coded) - 10641043816608

60MM
MERCURY ENTERPRISES, INC.
10-81660
In Commercial Distribution

  • 30641043816602 ()
  • 10641043816608 ()


  • Oropharyngeal airway, single-use

Guedel Airways (color coded) - 10641043816509

50MM
MERCURY ENTERPRISES, INC.
10-81650
In Commercial Distribution

  • 30641043816503 ()
  • 10641043816509 ()


  • Oropharyngeal airway, single-use

Guedel Airways (color coded) - 10641043816103

100MM
MERCURY ENTERPRISES, INC.
10-81610
In Commercial Distribution

  • 30641043816107 ()
  • 10641043816103 ()


  • Oropharyngeal airway, single-use

Berman Airways (color coded) - 10641043815908

90MM
MERCURY ENTERPRISES, INC.
10-81590
In Commercial Distribution

  • 30641043815902 ()
  • 10641043815908 ()


  • Oropharyngeal airway, single-use

Berman Airways (color coded) - 10641043815809

80MM
MERCURY ENTERPRISES, INC.
10-81580
In Commercial Distribution

  • 30641043815803 ()
  • 10641043815809 ()


  • Oropharyngeal airway, single-use

Berman Airways (color coded) - 10641043815700

70MM
MERCURY ENTERPRISES, INC.
10-81570
In Commercial Distribution

  • 30641043815704 ()
  • 10641043815700 ()


  • Oropharyngeal airway, single-use

Berman Airways (color coded) - 10641043815601

60MM
MERCURY ENTERPRISES, INC.
10-81560
In Commercial Distribution

  • 30641043815605 ()
  • 10641043815601 ()


  • Oropharyngeal airway, single-use

Berman Airways (color coded) - 10641043815502

50MM
MERCURY ENTERPRISES, INC.
10-81550
In Commercial Distribution

  • 30641043815506 ()
  • 10641043815502 ()


  • Oropharyngeal airway, single-use

Berman Airways (color coded) - 10641043815403

40MM
MERCURY ENTERPRISES, INC.
10-81540
In Commercial Distribution

  • 30641043815407 ()
  • 10641043815403 ()


  • Oropharyngeal airway, single-use

Berman Airways (color coded) - 10641043815106

110MM
MERCURY ENTERPRISES, INC.
10-81510
In Commercial Distribution

  • 30641043815100 ()
  • 10641043815106 ()


  • Oropharyngeal airway, single-use

Berman Airways (color coded) - 10641043815007

100MM
MERCURY ENTERPRISES, INC.
10-81500
In Commercial Distribution

  • 30641043815001 ()
  • 10641043815007 ()


  • Oropharyngeal airway, single-use

Williams Airway - 10641043812969

No Description
MERCURY ENTERPRISES, INC.
10-81296
In Commercial Distribution

  • 30641043812963 ()
  • 10641043812969 ()


  • Oropharyngeal airway, single-use

Williams Airway - 10641043812952

No Description
MERCURY ENTERPRISES, INC.
10-81295
In Commercial Distribution

  • 30641043812956 ()
  • 10641043812952 ()


  • Oropharyngeal airway, single-use

Guedel Airways - 10641043812907

No Description
MERCURY ENTERPRISES, INC.
10-81290
In Commercial Distribution

  • 30641043812901 ()
  • 10641043812907 ()


  • Oropharyngeal airway, single-use
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