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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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STAT PROFILE pHOx BASIC/PLUS/L/C WASTE LINE ASSEMBLY, EXTERNAL
NOVA BIOMEDICAL CORPORATION
pHOx/BASIC/PLUS/L/C
In Commercial Distribution

  • 00385480219266 ()
21926

  • Blood gas/haemoximetry analyser IVD, point-of-care
PureWick Female External Catheter, Not Made with Natural Rubber Latex, Kit
C. R. Bard, Inc.
PWF030K
In Commercial Distribution

  • 20801741183618 ()
  • 10801741183611 ()
  • 00801741183614 ()
PWF030K

  • Female wearable urinal, single-use
Self-sealing sterilization pouches with internal and external multi-variable (parameter) chemical indicator
Scican Ltd
SCI-SCP
Not in Commercial Distribution

  • 27540196001650 ()
  • 17540196001653 ()
  • 07540196001656 ()
SCI-SCP

  • Sterilization packaging, single-use
IntelliVue TcG10 Gas Modul for external transcutaneous O2 and CO2 measurement
Philips Medizin Systeme Böblingen GmbH
IntelliVue TcG10
Not in Commercial Distribution

  • 00884838020764 ()
865298

  • Transcutaneous blood gas monitoring system
Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz.
INNOVATIVE NEUROLOGICAL DEVICES LLC
Cervella CES
In Commercial Distribution

  • 00860001493306 ()
Cervella

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Alpha-Stim AID kit - US
Electromedical Products International, Inc.
AID
In Commercial Distribution

  • 00857869005260 ()


  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Alpha-Stim SCS kit
Electromedical Products International, Inc.
SCS
In Commercial Distribution

  • 00857869005208 ()


  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Alpha-Stim AID kit - China
Electromedical Products International, Inc.
AID
In Commercial Distribution

  • 00857869005017 ()
500

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Modius Calm is a non-invasive, home-use neurostimulation device that is indicated to treat Generalized Anxiety Disorder (GAD) in adults. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to deliver low-level electrical energy to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads that placed on the skin behind each ear.
NEUROVALENS LIMITED
MA1500
In Commercial Distribution

  • 05070002841210 ()


  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to deliver low-level electrical energy to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads that placed on the skin behind each ear.
NEUROVALENS LIMITED
MS1000
In Commercial Distribution

  • 05070002841203 ()


  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
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