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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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FloraSeal Mini Microbial Sealant
ADHEZION BIOMEDICAL, LLC
FS035T
In Commercial Distribution

  • M495FS035T0 ()
  • M495FS035T1 ()

  • Total Volume: .35 Milliliter
FS-035T

  • Surgical skin microbial sealant
13C-Spirulina Gastric Emptying Breath Test (GEBT)
ADVANCED BREATH DIAGNOSTICS, LLC
K021
In Commercial Distribution

  • M763K0211 ()


  • Carbon-13 breath test kit IVD
The ResQCPR system contains two ResQPODs and one ResQPump
ADVANCED CIRCULATORY SYSTEMS INC
12-0825-000
In Commercial Distribution

  • M5921208220000 ()
  • M5921208250001 ()
  • M5921208230001 ()


  • Cardiac resuscitator, manual
The ResQGARD ITD 7 is indicated for the temporary increase in blood circulation. The device is used to enhance circulation by lowering intrathoracic pressure in spontaneously breathing patients who experience poor circulation and low blood flow that may be indicated by low blood pressure. The device functions by adding selective inspiratory airway impedance within the respiratory circuit. Airway impedance is experienced when the patient spontaneously inspires. Expiratory impedance is negligible.
ADVANCED CIRCULATORY SYSTEMS INC
12-0707-000
In Commercial Distribution

  • M5921207070000 ()


  • Cardiopulmonary resuscitation kit, reusable
The ResQPOD ITD 10 is indicated for the temporary increase in blood circulation.
ADVANCED CIRCULATORY SYSTEMS INC
12-0242-000
In Commercial Distribution

  • M5921202420000 ()
  • M5921202420001 ()
  • M5921202420002 ()


  • Cardiopulmonary resuscitation impedance valve, inspiratory
The CirQPOD Intrathoracic Pressure Regulator (IPR) System provides IPR therapy, intended to increase circulation and blood pressure in non-spontaneously breathing patients. The CirQPOD employs a single use, disposable blower device connected to the CirQPOD Motor - used in combination with a ventilator source - to deliver a positive pressure breath (ventilation) to a patient. The CirQPOD’s mechanism of action derives from the physiologic principle that lower intrathoracic pressure will increase venous return to the heart. The increase in venous return results in increased cardiac output, circulation, and blood pressure. When inserted within a standard respiratory circuit between the patient and a ventilation source, the CirQPOD generates negative pressure during the expiratory phase to create sub-atmospheric intrathoracic pressure between the periods of positive pressure ventilations.
ADVANCED CIRCULATORY SYSTEMS INC
12-2415-000
In Commercial Distribution

  • M5921224150000 ()


  • Cardiopulmonary resuscitation impedance valve, inspiratory
STAINLESS STEEL KERRISON RONGEUR 10" 6MM BITE 40 DEGREE PIN EJECTOR
ADVANCED INSTRUMENTATION FOR MEDICINE,INC.
SS10-6MM40PIN
Not in Commercial Distribution

  • B509PINSS106MM40 ()


  • Spinal rongeur
KERRISON RONGEUR STAINLESS STEEL 9" 6MM 40 DEGREE
ADVANCED INSTRUMENTATION FOR MEDICINE,INC.
SS9-6MM40
Not in Commercial Distribution

  • B508SS96MM40 ()


  • Spinal rongeur
KERRISON RONGEUR STAINESS STEEL 9" 5MM 90 DEGREE
ADVANCED INSTRUMENTATION FOR MEDICINE,INC.
SS9-5MM90
Not in Commercial Distribution

  • B508SS95MM90 ()


  • Spinal rongeur
KERRISON RONGEUR STAINLESS STEEL 9" 5MM 40 DEGREE
ADVANCED INSTRUMENTATION FOR MEDICINE,INC.
SS9-5MM40
Not in Commercial Distribution

  • B508SS95MM40 ()


  • Spinal rongeur
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