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 Class Implantable

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Reusable SpO2 Sensor
APK Technology Co.,Ltd.
S810-960
In Commercial Distribution

  • 06946725548417 ()


  • Pulse Co-oximeter probe, reusable
Reusable SpO2 Sensor
APK Technology Co.,Ltd.
S810-690
In Commercial Distribution

  • 06946725548387 ()


  • Pulse Co-oximeter probe, reusable
DRE Compatible Adult Soft Reusable Short SpO2
APK Technology Co.,Ltd.
S403S-42D0
In Commercial Distribution

  • 06946725548295 ()


  • Pulse Co-oximeter probe, reusable
Direct Connect Nellcor OxiMax Compatible
APK Technology Co.,Ltd.
S410S-70P0
In Commercial Distribution

  • 06946725548288 ()


  • Pulse Co-oximeter probe, reusable
Compatible Risingmed RPM 900A Pediatric Soft
APK Technology Co.,Ltd.
S110S-1750
In Commercial Distribution

  • 06946725548257 ()


  • Pulse Co-oximeter probe, reusable
Reusable SpO2 Sensor Adult Soft
APK Technology Co.,Ltd.
S410S-020
In Commercial Distribution

  • 06946725548233 ()


  • Pulse Co-oximeter probe, reusable
Compatible Sinohero Pediatric Clip SpO2 Sensor
APK Technology Co.,Ltd.
S110-205D0
In Commercial Distribution

  • 06946725548189 ()


  • Pulse Co-oximeter probe, reusable
Reusable ECG Leadwire 5-Leads
APK Technology Co.,Ltd.
10403
In Commercial Distribution

  • 06946725548141 ()


  • Electrocardiographic lead set, reusable
The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
IB-STIM
In Commercial Distribution

  • B960NSS2031 ()
  • B960NSS203 ()
  • B960NSS2032 ()
  • B327NSS203 ()
  • B960NSS2033 ()
01-1020

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
S.T. Genesis
DYANSYS INDIA PRIVATE LIMITED
S.T. Genesis
In Commercial Distribution

  • 08908006064120 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
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