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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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CONSERVE® TOTAL A-CLASS® 44MM FEMORAL HEAD
Microport Orthopedics Inc.
38AC4400
In Commercial Distribution

  • M68438AC44001 ()

  • Outer Diameter: 44 Millimeter
38AC4400

  • Metallic femoral head prosthesis
CONSERVE® TOTAL A-CLASS® 42MM FEMORAL HEAD
Microport Orthopedics Inc.
38AC4200
In Commercial Distribution

  • M68438AC42001 ()

  • Outer Diameter: 42 Millimeter
38AC4200

  • Metallic femoral head prosthesis
CONSERVE® TOTAL A-CLASS® 40MM FEMORAL HEAD
Microport Orthopedics Inc.
38AC4000
In Commercial Distribution

  • M68438AC40001 ()

  • Outer Diameter: 40 Millimeter
38AC4000

  • Metallic femoral head prosthesis
CONSERVE® TOTAL A-CLASS® 38MM FEMORAL HEAD
Microport Orthopedics Inc.
38AC3800
In Commercial Distribution

  • M68438AC38001 ()

  • Outer Diameter: 38 Millimeter
38AC3800

  • Metallic femoral head prosthesis
CONSERVE® TOTAL A-CLASS® 36MM FEMORAL HEAD
Microport Orthopedics Inc.
38AC3600
In Commercial Distribution

  • M68438AC36001 ()

  • Outer Diameter: 36 Millimeter
38AC3600

  • Metallic femoral head prosthesis
LungFit PH Product Description The LungFit PH System generates nitric oxide (NO) from room air and delivers it to a mechanical ventilator breathing circuit in a controlled concentration from 0.1 to 80 ppm NO. The attached nitric oxide delivery module (NDM) measures the gas flow in the ventilator breathing circuit and delivers a controlled flow of nitric oxide enriched gas into the breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the ventilator breathing circuit just prior to inhalation by the patient, via a sampling line. The system is comprised of three sub-systems: The NO Generator with the NO2 Filter, the Nitric Oxide Backup and Bagging System, and the Gas Sampling and Monitoring System.
Beyond Air, Inc.
90002
In Commercial Distribution

  • B882900020 ()


  • Nitric oxide delivery unit, system-based
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80013
In Commercial Distribution

  • B882800130 ()


  • Nitric oxide delivery unit, system-based
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80012
In Commercial Distribution

  • B882800120 ()


  • Nitric oxide delivery unit, system-based
The 4170-2 is the Post Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-2
In Commercial Distribution

  • M706417021 ()
4170-2

  • Skin photodynamic therapy/phototherapy lamp
The 4170-1 is the Head Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-1
In Commercial Distribution

  • M706417011 ()
4170-1

  • Skin photodynamic therapy/phototherapy lamp
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