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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® - 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

Tubing Pack - 00607567203952

BO-RF32 Rotaflow
DATASCOPE CORP.
BO-T 6600
Not in Commercial Distribution

  • 00607567203952 ()
701052324

  • Cardiopulmonary bypass system centrifugal pump

JEM 400 Endotracheal Tube Changer - M996JEM4000

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 400 fits tubes with 7.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 400
In Commercial Distribution

  • M996JEM4002 ()
  • M996JEM4000 ()

  • Outer Diameter: 6.43 Millimeter
JEM 400

  • Endotracheal tube guide, single-use

JEM 360 Endotracheal Tube Changer - M996JEM3600

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 360 fits tubes with 6.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 360
In Commercial Distribution

  • M996JEM3602 ()
  • M996JEM3600 ()

  • Outer Diameter: 5.54 Millimeter
JEM 360

  • Endotracheal tube guide, single-use

JEM 350 Endotracheal Tube Changer - M996JEM3500

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 350 fits tubes with 5.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 350
In Commercial Distribution

  • M996JEM3502 ()
  • M996JEM3500 ()

  • Outer Diameter: 4.55 Millimeter
JEM 350

  • Endotracheal tube guide, single-use

JEM 340 Endotracheal Tube Changer - M996JEM3400

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 340 fits tubes with 4.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 340
In Commercial Distribution

  • M996JEM3402 ()
  • M996JEM3400 ()

  • Outer Diameter: 3.56 Millimeter
JEM 340

  • Endotracheal tube guide, single-use

JEM 325 Endotracheal Tube Changer - M996JEM3250

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 325 fits tubes with 2.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 325
In Commercial Distribution

  • M996JEM3252 ()
  • M996JEM3250 ()

  • Outer Diameter: 1.80 Millimeter
JEM 325

  • Endotracheal tube guide, single-use

JEM 401 Set of Endotracheal Tube Changers, (includes 9 sizes) - M996JEM4010

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 401 is a set of nine individually packaged endotracheal tube changers, with each fitting a different size endotracheal tube. The JEM 401 includes one each of JEM 325, JEM 330, JEM 340, JEM 350, JEM 355, JEM 360, JEM 365, JEM 370, JEM 400.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 401
In Commercial Distribution

  • M996JEM4010 ()

  • Outer Diameter: 6.43 Millimeter
  • Outer Diameter: 5.54 Millimeter
  • Outer Diameter: 4.55 Millimeter
  • Outer Diameter: 3.56 Millimeter
  • Outer Diameter: 2.57 Millimeter
  • Outer Diameter: 1.80 Millimeter
JEM 401

  • Endotracheal tube guide, single-use

JEM 370 Endotracheal Tube Changer - M996JEM3700

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 370 fits tubes with 7.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 370
In Commercial Distribution

  • M996JEM3702 ()
  • M996JEM3700 ()

  • Outer Diameter: 5.54 Millimeter
JEM 370

  • Endotracheal tube guide, single-use
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