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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Nihon Kohden-Philips 3L ECG Adapter
APK Technology Co.,Ltd.
A-CO-187
In Commercial Distribution

  • 16946725590536 ()
  • 06946725528884 ()
  • 16946725590932 ()


  • Electrocardiographic lead set, reusable
GE-Philips 5L ECG Adapter
APK Technology Co.,Ltd.
A-CO-178
In Commercial Distribution

  • 16946725590529 ()
  • 06946725528877 ()
  • 16946725590888 ()


  • Electrocardiographic lead set, reusable
GE-Philips 3L ECG Adapter
APK Technology Co.,Ltd.
A-CO-177
In Commercial Distribution

  • 16946725590512 ()
  • 06946725528860 ()
  • 16946725590871 ()


  • Electrocardiographic lead set, reusable
"IBP Adapter Cable Conpatible larguette ledex Abbott"
APK Technology Co.,Ltd.
IC-MQ-MX0
In Commercial Distribution

  • 06946725500101 ()


  • Electrical-only medical device connection cable, reusable
Philips Compatible IBP Adapter Cable for Medex Abbott Transducers
APK Technology Co.,Ltd.
IC-HP-MX0
In Commercial Distribution

  • 06946725500095 ()


  • Electrical-only medical device connection cable, reusable
BCI Compatible SpO2 Sensor, 9 Foot Cable: Pediatric Soft
APK Technology Co.,Ltd.
S110S-060
In Commercial Distribution

  • 06946725500071 ()


  • Pulse Co-oximeter probe, reusable
Biolight Compatible Digital Adult Soft SPO2 Sensor
APK Technology Co.,Ltd.
S403S-62D0
In Commercial Distribution

  • 06946725500064 ()


  • Pulse Co-oximeter probe, reusable
SpO2 Rubber Neonate Wrap
APK Technology Co.,Ltd.
10842
In Commercial Distribution

  • 06946725500057 ()


  • Electrical-only medical device connection cable, reusable
The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
Spark Biomedical Inc.
11-320-K
In Commercial Distribution

  • 00860005396986 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain. This is a subcomponent and is not transacted. See 810-P.
Spark Biomedical Inc.
810
In Commercial Distribution

  • 00860005396979 ()


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