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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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COE® SPACER TRAYS #30D Upper L, Lower R Perforated-Partial
Gc America Inc.
250301
In Commercial Distribution

  • D6582503062 ()
  • D6582503011 ()
  • D6582530124 ()
  • D6582503010 ()
250301

  • Dental impression tray, single-use
COE® SPACER TRAYS #22D Small Lower Perforated
Gc America Inc.
250221
In Commercial Distribution

  • D6582502262 ()
  • D6582502211 ()
  • D6582522124 ()
  • D6582502210 ()
250221

  • Dental impression tray, single-use
COE® SPACER TRAYS #21D Medium Lower Perforated
Gc America Inc.
250211
In Commercial Distribution

  • D6582502162 ()
  • D6582502111 ()
  • D6582521124 ()
  • D6582502110 ()
250211

  • Dental impression tray, single-use
COE® SPACER TRAYS #20D Large Lower Perforated
Gc America Inc.
250201
In Commercial Distribution

  • D6582520124 ()
  • D6582502062 ()
  • D6582502011 ()
  • D6582502010 ()
250201

  • Dental impression tray, single-use
COE® SPACER TRAYS Perforated Assorted Package
Gc America Inc.
250096
In Commercial Distribution

  • D6582500962 ()
  • D6582500961 ()
  • D6582501124 ()
  • D6582500960 ()
250096

  • Dental impression tray, single-use
COE® SPACER TRAYS #7D Small Upper Perforated
Gc America Inc.
250071
In Commercial Distribution

  • D6582500762 ()
  • D6582500711 ()
  • D6582507124 ()
  • D6582500710 ()
250071

  • Dental impression tray, single-use
COE® SPACER TRAYS #4D Medium Upper Perforated
Gc America Inc.
250041
In Commercial Distribution

  • D6582500462 ()
  • D6582500411 ()
  • D6582504124 ()
  • D6582500410 ()
250041

  • Dental impression tray, single-use
COE® SPACER TRAYS #1D Large Upper Perforated
Gc America Inc.
250011
In Commercial Distribution

  • D6582500124 ()
  • D6582500162 ()
  • D6582500111 ()
  • D6582500110 ()
250011

  • Dental impression tray, single-use
The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The BiWaze Clear System may be used with a patient interface like face mask, mouthpiece, a trach adapter to a patient’s endotracheal or tracheostomy tube. It is for use on adult or paediatric patients in acute, post-acute, and home care environments. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting
Abmrc LLC
BK181
In Commercial Distribution

  • B965BK367 ()
  • B965BK181 ()
  • B965BK368 ()
BK181

  • In-exsufflation/lung-oscillation airway secretion-clearing system
The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH.
Beyond Air, Inc.
90031
In Commercial Distribution

  • B882900310 ()
  • B882900311 ()
  • B882900312 ()


  • Nitric oxide delivery system, secondary
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