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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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Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder
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 weighing approximately 5 grams 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.
KEY ELECTRONICS, INC.
IB-STIM
In Commercial Distribution

  • B327NSS2032 ()
  • B327NSS203 ()
  • B327NSS2031 ()
01-1020

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS MFS is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS MFS is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS MFS offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
MFS
In Commercial Distribution

  • B327NSS202 ()
  • B327NSS2022 ()
  • B327NSS2021 ()
01-1011-NSS/MFS

  • Acupuncture electrical stimulation system
The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
Neurostim
In Commercial Distribution

  • B327NSS201 ()
  • B327NSS2012 ()
  • B327NSS2011 ()
01-1021

  • Acupuncture electrical stimulation system
The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination. NSS-2 BRIDGE stimulator is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS-2 BRIDGE stimulator is placed behind the patient’s ear and connected to stimulation needles on the auricle. NSS-2 BRIDGE stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
Bridge
In Commercial Distribution

  • B327NSS200 ()
  • B327NSS2002 ()
  • B327NSS2001 ()
01-1017-NSS-2/Bridge

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Q-Lase Adjustable Sheath
OPTICAL INTEGRITY INC
11515
In Commercial Distribution

  • B145115152 ()
  • B145115151 ()
  • B145115150 ()

  • Outer Diameter: 800 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
STERILE ACCESS & RETURN LINE SET
MOLDED PRODUCTS, INC.
UM-872-36
In Commercial Distribution

  • B144UM872360 ()
  • B144UM872361 ()
  • B144UM872364 ()
UM-872-36

  • Haemodialysis blood tubing set, single-use
Sterile DIN to Male DIN Connector
MOLDED PRODUCTS, INC.
MPC-875
In Commercial Distribution

  • B144MPC8753 ()
  • B144MPC8751 ()
  • B144MPC8750 ()
MPC-875

  • Haemodialysis blood tubing set, single-use
Sterile Bloodline Extension
MOLDED PRODUCTS, INC.
MPC-870
In Commercial Distribution

  • B144MPC8703 ()
  • B144MPC8701 ()
  • B144MPC8700 ()
MPC-870

  • Haemodialysis blood tubing set, single-use
Sterile Female Luer to Male DIN Connector
MOLDED PRODUCTS, INC.
MPC-865
In Commercial Distribution

  • B144MPC8651 ()
  • B144MPC8650 ()
  • B144MPC8653 ()
MPC-865

  • Haemodialysis blood tubing set, single-use
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