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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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Anhui Kangda Medical Products Co.,Ltd.
KD206
In Commercial Distribution

  • 06936018500918 ()
  • 06936018500925 ()
  • 06936018500932 ()


  • Basic intravenous administration set, invasive
Neubac brand of over the counter transcutaneous electrical nerve stimulator for analgesic pain relief in the lower back.
HOLLYWOG, LLC
11.3000
Not in Commercial Distribution

  • 00853096004083 ()
  • 00853096004144 ()
  • 00853096004236 ()

  • Height: 90 Millimeter
  • Width: 191 Millimeter
  • Outer Diameter: 18 Millimeter
11.3000

  • Analgesic transcutaneous electrical nerve stimulation system
WiTouch brand over the counter transcutaneous electrical nerve simulator to be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis.
HOLLYWOG, LLC
11.1500
In Commercial Distribution

  • 00853096004021 ()

  • Outer Diameter: 18 Millimeter
  • Height: 90 Millimeter
  • Width: 191 Millimeter
11.1500

  • Analgesic transcutaneous electrical nerve stimulation system
WiTouch brand over the counter transcutaneous electrical nerve simulator for analgesic pain relief in the lower back
HOLLYWOG, LLC
11.1510
Not in Commercial Distribution

  • 00853096004014 ()
  • 00853096004243 ()
  • 00853096004335 ()

  • Height: 90 Millimeter
  • Width: 191 Millimeter
  • Outer Diameter: 18 Millimeter
11.1510

  • Analgesic transcutaneous electrical nerve stimulation system
Aurix XL is a phlebotomy convenience kit
Nuo Therapeutics, Inc.
AUXP-2T
In Commercial Distribution

  • 00852714003187 ()


  • Phlebotomy kit
Angel Blood Access Kits (NA) Single Unit (kit or Tray) with 966100258 Outer Box Label NA
NUO THERAPEUTICS INC
976000502
In Commercial Distribution

  • 00852714003033 ()


  • Phlebotomy kit
A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.
Senzime AB (Publ.)
Pediatric
In Commercial Distribution

  • 00851540007161 ()
RMI-53040

  • Monitoring spirometer, electrical
A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron PadSet via the ExSpiron Patient Cable, the ExSpiron 2Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 2Xi Monitor can be integrated into a medical facility's nurse call system.
Senzime AB (Publ.)
RMI-54000
In Commercial Distribution

  • 00851540007147 ()
  • 00851540007154 ()


  • Monitoring spirometer, electrical
A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.
Senzime AB (Publ.)
Adult
In Commercial Distribution

  • 00851540007048 ()
  • 00851540007116 ()
RMI-51110

  • Monitoring spirometer, electrical
Noninvasive, insulated, electrical cable designed to connect the ExSpiron Monitor to the ExSpiron PadSet.
Respiratory Motion Inc.
Patient Cable, 8'
In Commercial Distribution

  • 00851540007017 ()
  • 00851540007093 ()
RMI-51130

  • Monitoring spirometer, electrical
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