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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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LungFit PH Breathing Circuit 1 Kit - B882800130

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

LungFit PH Breathing Circuit 2 Kit - B882800120

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

Prodigy MRI™ - 05415067017093

IPG, 16 CH, Rechargeable
ST. JUDE MEDICAL, INC.
3772
In Commercial Distribution

  • 05415067017093 ()
3772

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

SJM™ Masters Series - 05415067004857

No Description
ST. JUDE MEDICAL, INC.
AJ-501
In Commercial Distribution

  • 05415067004857 ()

  • Outer Diameter: 29 Millimeter
29AJ-501

  • Aortic bi-leaflet mechanical heart valve prosthesis

NA - 05415067026996

Port Plug, DRG
ST. JUDE MEDICAL, INC.
7108
In Commercial Distribution

  • 15415067026993 ()
  • 05415067026996 ()
7108

  • Implantable pulse generator port plug

Prodigy™ - 05414734405485

IPG
ST. JUDE MEDICAL, INC.
3799
In Commercial Distribution

  • 05414734405485 ()
3799

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

SJM™ Masters Series HP - 05414734005883

Aortic HP Rotatable Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
19AHPJ-505
In Commercial Distribution

  • 05414734005883 ()

  • Outer Diameter: 19 Millimeter
19AHPJ-505

  • Aortic bi-leaflet mechanical heart valve prosthesis

SJM™ Masters Series HP - 05414734005784

Aortic Expanded HP Rotatable Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
17AEHPJ-505
In Commercial Distribution

  • 05414734005784 ()

  • Outer Diameter: 17 Millimeter
17AEHPJ-505

  • Aortic bi-leaflet mechanical heart valve prosthesis

SJM™ Masters Series - 05414734055345

Aortic PTFE Rotatable Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
31ATJ-503
In Commercial Distribution

  • 05414734055345 ()

  • Outer Diameter: 31 Millimeter
31ATJ-503

  • Aortic bi-leaflet mechanical heart valve prosthesis

SJM™ Masters Series - 05414734055321

Aortic PTFE Rotatable Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
29ATJ-503
In Commercial Distribution

  • 05414734055321 ()

  • Outer Diameter: 29 Millimeter
29ATJ-503

  • Aortic bi-leaflet mechanical heart valve prosthesis
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