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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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Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
Oscor Inc.
SSC9
In Commercial Distribution

  • 00885672009885 ()
  • 10885672009882 ()

  • Sheath Length 15.32 cm
  • Lumen/Inner Diameter: 3 Millimeter
  • Syringe 10 cc
SSC9

  • Vascular catheter introduction set, nonimplantable
PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXMK2330
In Commercial Distribution

  • 07460691959217 ()
  • 57460691959212 ()

  • TOTAL VOLUME: 3 CC, LENGTH: 47 INCH
PXMK2330

  • Invasive-pressure external transducer, single-use
PRESSURE MONITORING SET
Edwards Lifesciences LLC
PX266C
In Commercial Distribution

  • 07460691958395 ()
  • 57460691958390 ()

  • TOTAL VOLUME: 3 CC, LENGTH: 66 INCH
PX266C

  • Invasive-pressure external transducer, single-use
PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXVJ0711
In Commercial Distribution

  • 07460691954489 ()
  • 57460691954484 ()

  • TOTAL VOLUME: 30 CC, LENGTH: 52 INCH
PXVJ0711

  • Arterial blood sampling kit
  • Invasive-pressure external transducer, single-use
Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
Oscor Inc.
SSCL9
Not in Commercial Distribution

  • 30891492002426 ()
  • 00891492002425 ()

  • Sheath Length 19.13 cm
  • Syringe 10 cc
SSCL9

  • Vascular catheter introduction set, nonimplantable
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258415 ()


  • Laboratory refrigerator/freezer
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258408 ()


  • Laboratory refrigerator/freezer
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
Evok 1600 Wireless
In Commercial Distribution

  • 00851362008070 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX8
In Commercial Distribution

  • 00851362008056 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX7
In Commercial Distribution

  • 00851362008018 ()


  • Air-conduction hearing aid, behind-the-ear
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