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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SPU SmartVest Wrap® – S-Small
ELECTROMED, INC.
SW-15/25-1
In Commercial Distribution

  • B102060145S0200 ()
SW-15/25-1

  • Chest-oscillation airway secretion-clearing system vest
MASK,TRACH,PED,CURAPLEX,SPU
BOUND TREE MEDICAL, LLC
301-183
In Commercial Distribution

  • 00810071630873 ()
  • 00810071631276 ()
301-183

  • Tracheostomy mask, oxygen
MASK,VENTURI,ADL,CURAPLEX,SPU
BOUND TREE MEDICAL, LLC
301-191
In Commercial Distribution

  • 00812277036374 ()
  • 00812277036367 ()
301-191

  • Venturi oxygen face mask
Thermal Cap, Universal Size, SPU, 1-ct
Dignitana AB
800-1104
In Commercial Distribution

  • 00850036106234 ()
800-1104

  • Scalp cooling system, hair loss
Cooling Wrap, Small Size, SPU, 1-ct
Dignitana AB
800-1103
In Commercial Distribution

  • 00850036106210 ()
800-1103

  • Scalp cooling system, hair loss
Cooling Wrap, Standard Size, SPU, 1-ct
Dignitana AB
800-1102
In Commercial Distribution

  • 00850036106197 ()
800-1102

  • Scalp cooling system, hair loss
SPU Gauge,Yellow/White, GE PL
AMERICAN DIAGNOSTIC CORP
809D
In Commercial Distribution

  • 00634782562731 ()
  • 00634782062927 ()
809D

  • Aneroid manual sphygmomanometer
SPU Cuff, 2 Tube,Large Adult
AMERICAN DIAGNOSTIC CORP
8400X-10
Not in Commercial Distribution

  • 00634782850166 ()
  • 00634782050368 ()

  • Large Adult, 31-40cm
8400X-10

  • Blood pressure cuff, reusable
ADTEMP I SPU Digital,Thermometer Kit
AMERICAN DIAGNOSTIC CORP
412K
In Commercial Distribution

  • 00634782548339 ()
  • 00634782848330 ()
  • 00634782048556 ()
412K

  • Intermittent electronic patient thermometer
PROSCOPE SPU Infant Scope,31", Black
AMERICAN DIAGNOSTIC CORP
676BKH
In Commercial Distribution

  • 00634782525019 ()
  • 00634782825010 ()
  • 00634782025090 ()
676BKH

  • Mechanical external stethoscope
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