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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No Description
LED TECHNOLOGIES INC
RVGLOAC
In Commercial Distribution

  • B347RVGLOAC1 ()
  • B347RVGLOAC0 ()
  • B347RVGLOAC2 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
FLJOINT
In Commercial Distribution

  • B347FLJOINT1 ()
  • B347FLJOINT0 ()
  • B347FLJOINT2 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA570610
In Commercial Distribution

  • B347BA5706101 ()
  • B347BA5706100 ()
  • B347BA5706102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA568810
In Commercial Distribution

  • B347BA5688101 ()
  • B347BA5688100 ()
  • B347BA5688102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA568210
In Commercial Distribution

  • B347BA5682101 ()
  • B347BA5682100 ()
  • B347BA5682102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA568110
In Commercial Distribution

  • B347BA5681101 ()
  • B347BA5681100 ()
  • B347BA5681102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567410
In Commercial Distribution

  • B347BA5674102 ()
  • B347BA5674101 ()
  • B347BA5674100 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567210
Not in Commercial Distribution

  • B347BA5672101 ()
  • B347BA5672100 ()
  • B347BA5672102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567010
Not in Commercial Distribution

  • B347BA5670102 ()
  • B347BA5670101 ()
  • B347BA5670100 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
5756
In Commercial Distribution

  • B34757561 ()
  • B34757560 ()
  • B34757562 ()


  • Blue/red/infrared phototherapy lamp
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
1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, reusable
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MA1251
Not in Commercial Distribution

  • B353MA12512 ()
  • B353MA12511 ()
  • B353MA12513 ()
MA1251_US

  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1253
In Commercial Distribution

  • B353LP12532 ()
  • B353LP12531 ()
  • B353LP12533 ()
LP1253_US

  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
LP1110
Not in Commercial Distribution

  • B353LP11103 ()
  • B353LP11102 ()
  • B353LP11101 ()


  • Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1210
Not in Commercial Distribution

  • B353IM12103 ()
  • B353IM12102 ()
  • B353IM12101 ()


  • Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution

  • B353IM11103 ()
  • B353IM11102 ()
  • B353IM11101 ()


  • Electrocardiography telemetric monitoring system
Wired TENS+EMS+HEAT Replacement Gel Pads
BEAR DOWN CONSULTING
PETNEMPD5
In Commercial Distribution

  • B311PETNEMPD51 ()
  • B311PETNEMPD5 ()
  • B311PETNEMPD52 ()


  • Transcutaneous electrical stimulation electrode, single-use
Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets
BEAR DOWN CONSULTING
PETNEMPD2
In Commercial Distribution

  • B311PETNEMPD21 ()
  • B311PETNEMPD2 ()
  • B311PETNEMPD22 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
BEAR DOWN CONSULTING
PETNEMHT
In Commercial Distribution

  • B311PETNEMHT1 ()
  • B311PETNEMHT0 ()
  • B311PETNEMHT2 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
BEAR DOWN CONSULTING
PEPULSE-RT
In Commercial Distribution

  • B311PEPULSERT0 ()
  • B311PEPULSERT1 ()
  • B311PEPULSERT2 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS5
In Commercial Distribution

  • B311PEHTNPDS51 ()
  • B311PEHTNPDS50 ()
  • B311PEHTNPDS52 ()


  • Transcutaneous electrical stimulation electrode, single-use
Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS2
In Commercial Distribution

  • B311PEHTNPDS21 ()
  • B311PEHTNPDS20 ()
  • B311PEHTNPDS22 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
THERAVANT CORPORATION
30TC03000AA
In Commercial Distribution

  • B30530TC0300 ()
  • B30530TC0301 ()
  • B30530TC0302 ()
30TC030

  • Multi-modality skin surface treatment system generator
No Description
THERAVANT CORPORATION
20TC12900AA
In Commercial Distribution

  • B30520TC1290 ()
  • B30520TC1292 ()
  • B30520TC1291 ()
20TC129

  • Multi-modality skin surface treatment system generator
CryoPRO™-5 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0442
In Commercial Distribution

  • B039SGI04421 ()
  • B039SGI04420 ()
  • B039SGI04429 ()


  • Blood cell freeze/thaw system
SynGenX®-1000 Disposable Cartridge
Thermogenesis Corp.
SGI-0305
In Commercial Distribution

  • B039SGI03050 ()
  • B039SGI03051 ()
  • B039SGI03059 ()


  • Umbilical cord blood collection set
CryoPRO™-2 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0091
In Commercial Distribution

  • B039SGI00911 ()
  • B039SGI00910 ()
  • B039SGI00919 ()


  • Blood cell freeze/thaw system
Replacement canister kit and catheters for 7000-MVP
B.L.S. Systems Limited
7000-AD
In Commercial Distribution

  • B0027000AD9 ()
  • B0027000AD0 ()
  • B0027000AD2 ()
7000-AD

  • Emergency airway clearance suction pump, manual
Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)
B.L.S. Systems Limited
6210-U
In Commercial Distribution

  • B0026210U7 ()
  • B0026210U0 ()
  • B0026210U9 ()

  • Child
6210-U

  • Non-rebreathing oxygen face mask
O-Mask Oxygen Mask, Child
B.L.S. Systems Limited
6210
In Commercial Distribution

  • B00262107 ()
  • B00262100 ()
  • B00262109 ()

  • Child
6210

  • Non-rebreathing oxygen face mask
Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)
B.L.S. Systems Limited
6205-U
In Commercial Distribution

  • B0026205U7 ()
  • B0026205U0 ()
  • B0026205U9 ()

  • Small Adult
6205-U

  • Non-rebreathing oxygen face mask
O-Mask Oxygen Mask, Small Adult
B.L.S. Systems Limited
6205
In Commercial Distribution

  • B00262057 ()
  • B00262050 ()
  • B00262059 ()

  • Small Adult
6205

  • Non-rebreathing oxygen face mask
Rescuer O-Mask with Universal Tubing (Large Adult)
B.L.S. Systems Limited
6200-U
In Commercial Distribution

  • B0026200U0 ()
  • B0026200U7 ()
  • B0026200U9 ()

  • Large Adult
6200-U

  • Non-rebreathing oxygen face mask
O-Mask Oxygen Mask, Large Adult
B.L.S. Systems Limited
6200
In Commercial Distribution

  • B00262007 ()
  • B00262000 ()
  • B00262009 ()

  • Large Adult
6200

  • Non-rebreathing oxygen face mask
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