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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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Gesiva Medical - B598GMMHT0001

No Description
GESIVA MEDICAL LLC
Medium High Tension Ring
In Commercial Distribution

  • B598GMMHT0001 ()
  • B598GMMHT0002 ()
  • B598GMTRK0001 ()


  • Penile vacuum device

TroClear - B606TC80

Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear TM is used in the camera port after a dirty laparoscopic camera is pulled through the trocar. TroClear TM squeegees the canula clean in a single pass, then captures the debris inside a sheath prior to withdraw to ensure a clean canula for camera re-entry. TroClear TM can be rinsed clean and reused multiple times per patient per IFU.
Mednium Corporation
TC8
In Commercial Distribution

  • B606TC86 ()
  • B606TC80 ()
  • B606TC87 ()
TC8

  • Surgical instrument/endoscope cleaning utensil, single-use

TroClear - B606TC50

Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear TM is used in the camera port after a dirty laparoscopic camera is pulled through the trocar. TroClear TM squeegees the canula clean in a single pass, then captures the debris inside a sheath prior to withdraw to ensure a clean canula for camera re-entry. TroClear TM can be rinsed clean and reused multiple times per patient per IFU.
Mednium Corporation
TC5
In Commercial Distribution

  • B606TC56 ()
  • B606TC50 ()
  • B606TC57 ()
TC5

  • Surgical instrument/endoscope cleaning utensil, single-use

TroClear - B606TC10SPD1

Hospital SPD trocar squeegee cleaning system is a non-sterile multiple use per IFU medical device. TroClear SPD TM cleans debris inside the trocar canula, TroClear TM SPD squeegees the canula clean in a single pass. TroClear TM SPD can be rinsed clean and reused multiple times per IFU.
Mednium Corporation
TC10SPD
In Commercial Distribution

  • B606TC10SPD6 ()
  • B606TC10SPD1 ()
  • B606TC10SPD7 ()
TC10SPD

  • Surgical instrument/endoscope cleaning utensil, reusable

Vios Monitoring System Pulse Oximetry Sensor - B595L2050R0

The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions. The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution

  • B595L2050R0 ()
  • B595L2050R1 ()
  • B595L2050R2 ()
L2050R

  • Pulse oximeter probe, reusable
  • Pulse Co-oximeter probe, reusable

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

SH 75-Y Barbed Tubing Adapter - M996SH75Y0

The SH 75-Y Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 75-Y - Yellow
In Commercial Distribution

  • M996SH75Y5 ()
  • M996SH75Y0 ()
  • M996SH75Y4 ()
SH 75-Y

  • Oxygen administration kit

SH 75-W Barbed Tubing Adapter - M996SH75W0

The SH 75-W Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 75-W - White
In Commercial Distribution

  • M996SH75W5 ()
  • M996SH75W0 ()
  • M996SH75W4 ()
SH 75-W

  • Oxygen administration kit

SH 75-G Barbed Tubing Adapter - M996SH75G0

The SH 75-G Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 75-G - Green
In Commercial Distribution

  • M996SH75G5 ()
  • M996SH75G0 ()
  • M996SH75G4 ()
SH 75-G

  • Oxygen administration kit

SH 75-C Barbed Tubing Adapter - M996SH75C0

The SH 75-C Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 75-C - Clear
In Commercial Distribution

  • M996SH75C5 ()
  • M996SH75C0 ()
  • M996SH75C4 ()
SH 75-C

  • Oxygen administration kit

SH 75-BL Barbed Tubing Adapter - M996SH75BL0

The SH 75-BL Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 75-BL - Blue
In Commercial Distribution

  • M996SH75BL5 ()
  • M996SH75BL0 ()
  • M996SH75BL4 ()
SH 75-BL

  • Oxygen administration kit

SH 75-BK Barbed Tubing Adapter - M996SH75BK0

The SH 75-BK Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 75-BK - Black
In Commercial Distribution

  • M996SH75BK5 ()
  • M996SH75BK0 ()
  • M996SH75BK4 ()
SH 75-BK

  • Oxygen administration kit

SH 74-Y Barbed Tubing Adapter - M996SH74Y0

The SH 74-Y Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 74-Y - Yellow
In Commercial Distribution

  • M996SH74Y5 ()
  • M996SH74Y0 ()
  • M996SH74Y4 ()
SH 74-Y

  • Oxygen administration kit

SH 74-W Barbed Tubing Adapter - M996SH74W0

The SH 74-W Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 74-W - White
In Commercial Distribution

  • M996SH74W5 ()
  • M996SH74W0 ()
  • M996SH74W4 ()
SH 74-W

  • Oxygen administration kit

SH 74-G Barbed Tubing Adapter - M996SH74G0

The SH 74-G Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 74-G - Green
In Commercial Distribution

  • M996SH74G5 ()
  • M996SH74G0 ()
  • M996SH74G4 ()
SH 74-G

  • Oxygen administration kit

SH 74-C Barbed Tubing Adapter - M996SH74C0

The SH 74-C Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 74-C - Clear
In Commercial Distribution

  • M996SH74C5 ()
  • M996SH74C0 ()
  • M996SH74C4 ()
SH 74-C

  • Oxygen administration kit

SH 74-BL Barbed Tubing Adapter - M996SH74BL0

The SH 74-BL Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 74-BL - Blue
In Commercial Distribution

  • M996SH74BL5 ()
  • M996SH74BL0 ()
  • M996SH74BL4 ()
SH 74-BK

  • Oxygen administration kit

SH 74-BK Barbed Tubing Adapter - M996SH74BK0

The SH 74-BK Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 74-BK - Black
In Commercial Distribution

  • M996SH74BK5 ()
  • M996SH74BK0 ()
  • M996SH74BK4 ()
SH 74-BK

  • Oxygen administration kit

SH 7-47 Nose Clip - M996SH7470

SH 7-47 Nose Clip holds patient's nostrils closed during testing and treatment. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 7-47
In Commercial Distribution

  • M996SH7476 ()
  • M996SH7470 ()
  • M996SH7475 ()
SH 7-47

  • Nose clip, single-use

SH 7-2 Five-in-One Connector - M996SH720

SH 7-2 Five-in-One Connector connects tubing with inside diameters from 3/16" to 7/16". Barbed edges on each step help to prevent disconnects. Single Patient Use
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 7-2
In Commercial Distribution

  • M996SH725 ()
  • M996SH720 ()
  • M996SH724 ()
SH 7-2

  • Straight/elbow breathing circuit connector, single-use

RTC 26-C Inline Aerosol Adapter - M996RTC26C0

The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing. The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 26-C
In Commercial Distribution

  • M996RTC26C5 ()
  • M996RTC26C0 ()
  • M996RTC26C4 ()
RTC 26-C

  • Metered dose inhaler

RTC 24-VP Universal Metered Dose Inhaler Adapter - M996RTC24VP0

The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-VP MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-VP MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-VP MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 24-VP
In Commercial Distribution

  • M996RTC24VP4 ()
  • M996RTC24VP0 ()
  • M996RTC24VP5 ()


  • Metered dose inhaler

KC 212-D 90 degree Angle Wye Connector - M996KC212D0

KC 212-D Wye connector with one - 18mm ID/22mm OD nebulizer port x (3) 22mm OD ports. Fits components of adult ventilator circuits. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 212-D
In Commercial Distribution

  • M996KC212D6 ()
  • M996KC212D0 ()
  • M996KC212D5 ()
KC 212-D

  • Y-piece breathing circuit connector, single-use

KC 2124 Adapter - M996KC21240

General Adapter - 15mm ID/22mm OD x 15mm ID/22mm OD. Fits components of adult ventilator circuits/CPAP systems. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 2124
In Commercial Distribution

  • M996KC21246 ()
  • M996KC21240 ()
  • M996KC21244 ()
KC 2124

  • Straight/elbow breathing circuit connector, single-use
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