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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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IV Start Kit with Site-loc, Skin Prep, Gauze, TQ, Tape, Ext Set, Flush
BOUND TREE MEDICAL, LLC
8600-01282
In Commercial Distribution

  • 00817617029122 ()
  • 00810094572518 ()
8600-01282

  • Peripheral intravenous catheterization support kit
Curaplex IV Start Kit with Tegaderm, Alcohol Pad, 2x2, Tape, Bandage, LF Tourniquet
BOUND TREE MEDICAL, LLC
670069-KIT
In Commercial Distribution

  • 00817617021218 ()
670069-KIT

  • Peripheral intravenous catheterization support kit
Hi-oxygen mask adult non-rebreathing reservoir bag with 7ft Tube(universal connetor on one
BESMED HEALTH BUSINESS CORP.
OM-81217
In Commercial Distribution

  • 04716770812175 ()


  • Respiratory oxygen therapy system
HI-OXYGEN MASK ADULT, WITH 7FT TUBE (UNIVERSAL CONNECTOR ON ONE SIDE),SINGLE PACKING
BESMED HEALTH BUSINESS CORP.
OM-81211
Not in Commercial Distribution

  • 04716770812113 ()


  • Respiratory oxygen therapy system
Spirometer, manometer connecting pressure cap with 14" tubing and relief port - 50/cs
SALTER LABS
6002-0-50
In Commercial Distribution

  • 00607411600012 ()
6002-0-50

  • Peak flow meter, manual
ConstaVac CBCII Blood Conservation Kit with 3/16” Round PVC Drain & Double Trocar
3T MEDICAL SYSTEMS, INC.
225-028-626
In Commercial Distribution

  • 00855168008227 ()
  • 00855168008210 ()

  • 4.8 Millimeter
225-028-626

  • Whole-blood-recovery autotransfusion system, powered
ConstaVac CBCII Blood Conservation Kit with 1/4” Round PVC Drain & Curved Trocar
3T MEDICAL SYSTEMS, INC.
225-028-516
Not in Commercial Distribution

  • 00855168008142 ()
  • 00855168008135 ()

  • 6.4 Millimeter
225-028-516

  • Whole-blood-recovery autotransfusion system, powered
ConstaVac CBCII Blood Conservation Kit with 1/8” Round PVC Drain & Curved Trocar
3T MEDICAL SYSTEMS, INC.
225-028-514
Not in Commercial Distribution

  • 00855168008128 ()
  • 00855168008111 ()

  • 3.2 Millimeter
225-028-514

  • Whole-blood-recovery autotransfusion system, powered
In Touch BG 200 Blood Glucose Meter with Charger Adapter and USB Cable
LIVONGO HEALTH, INC
BG200
In Commercial Distribution

  • 00853553005035 ()
FG00163

  • Home-use/point-of-care glucose analyser IVD, battery-powered
VistaHub-WiFi relay device to be used with the Vista Solution and VitalPatch biosensor.
Vital Connect, Inc.
8001-01
In Commercial Distribution

  • 00850490007177 ()
8001-01

  • Electrocardiography telemetric monitoring system
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