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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New Hampshire BFK - 10 Refill
Certified Safety Manufacturing, Inc.
FKR208-008
In Commercial Distribution

  • 00766588087085 ()
FKR208-008

  • First aid kit, medicated
10PW - New Hampshire Body Fluid
Certified Safety Manufacturing, Inc.
FK208-008
In Commercial Distribution

  • 00766588080086 ()
FK208-008

  • First aid kit, medicated
24M - New Hampshire SBKNSTD - Metal
Certified Safety Manufacturing, Inc.
S202-450
In Commercial Distribution

  • 00766588024509 ()
S202-450

  • Non-woven gauze roll/sheet
  • Adhesive bandage
  • First aid kit, medicated
  • Non-rebreathing valve, single-use
  • Cardiopulmonary resuscitation mask, single-use
  • Non-woven gauze pad
  • Dressing-fixation skin adhesive tape, non-silicone
  • Eye pad
24PW - New Hampshire SBKNSTD - Poly White
Certified Safety Manufacturing, Inc.
S202-451
In Commercial Distribution

  • 00766588024516 ()
S202-451

  • Adhesive bandage
  • First aid kit, medicated
  • Non-woven gauze roll/sheet
  • Dressing-fixation skin adhesive tape, non-silicone
  • Non-woven gauze pad
  • Non-rebreathing valve, single-use
  • Eye pad
  • Cardiopulmonary resuscitation mask, single-use
Viral Collection and Transport Kit, University of New Hampshire Only
AERO-MED, LLC
AMM4600
In Commercial Distribution

  • 50885380181243 ()
  • 10885380181245 ()
AMM4600

  • General specimen transport medium collection kit, non-sterile
A buffered and filtered New Methylene Blue that can be used with control and patient samples. Contains 2 vials.
STRECK, INC.
285410
In Commercial Distribution

  • 30844509000410 ()

  • Total Volume: 15 Milliliter
285410

  • New methylene blue solution IVD
A buffered and filtered New Methylene Blue that can be used with control and patient samples. Contains 4 vials.
STRECK, INC.
285404
In Commercial Distribution

  • 30844509000403 ()

  • Total Volume: 3.0 Milliliter
285404

  • New methylene blue solution IVD
A buffered and filtered New Methylene Blue that can be used with control and patient samples. Contains 1 vial.
STRECK, INC.
285005
In Commercial Distribution

  • 20844509000413 ()

  • Total Volume: 15 Milliliter
285005

  • New methylene blue solution IVD
A buffered and filtered New Methylene Blue that can be used with control and patient samples. Contains 1 vial.
STRECK, INC.
285004
In Commercial Distribution

  • 20844509000406 ()

  • Total Volume: 3.0 Milliliter
285004

  • New methylene blue solution IVD
EMYO®100S is a Single Channel EMG System for dysphagia rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO® 100S
In Commercial Distribution

  • 00852423006486 ()
EM100S

  • Psychophysiological biofeedback system
EMYO® 200S is a dual channel EMG System for dysphagia rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO® 200S
In Commercial Distribution

  • 00852423006479 ()
EM200S

  • Psychophysiological biofeedback system
Morpheus® Transperineal Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
RTTU
In Commercial Distribution

  • 00852423006462 ()
RTTU

  • Extracorporeal ultrasound imaging transducer, hand-held
EMYO®100 is a Single Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO®100
In Commercial Distribution

  • 00852423006455 ()
EM100-N

  • Psychophysiological biofeedback system
EMYO®200 is a Dual Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO®200
In Commercial Distribution

  • 00852423006448 ()
EM200

  • Psychophysiological biofeedback system
9250-ST Telesis® ST Software for Speech Therapy MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250-ST
In Commercial Distribution

  • 00852423006431 ()
9250-ST

  • Biofeedback system application software
Pathway® NMR 200 Dual Channel Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
NMR 200
In Commercial Distribution

  • 00852423006394 ()
NMR 200

  • Perineometer
  • Psychophysiological biofeedback system
Uroflowmetry WiFLOW® System
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
WI-LC
In Commercial Distribution

  • 00852423006387 ()
WLC

  • Urine flowmeter, reusable
  • Urodynamic measurement system
Pathway® Musculoskeletal Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MSK
In Commercial Distribution

  • 00852423006370 ()
MSK

  • Extracorporeal ultrasound imaging transducer, hand-held
Pathway® Ultrasound Imaging System for Lumbopelvic Rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TUI
In Commercial Distribution

  • 00852423006363 ()
TUI

  • Extracorporeal ultrasound imaging transducer, hand-held
10-15 MHz 360° Endoanal Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
RTCU
In Commercial Distribution

  • 00852423006356 ()
RTCU

  • Extracorporeal ultrasound imaging transducer, hand-held
5-12 MHz 90° Endovaginal Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
RTTV
In Commercial Distribution

  • 00852423006349 ()
RTTV

  • Extracorporeal ultrasound imaging transducer, hand-held
Pathway® RealTime Ultrasound
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
N/A
Not in Commercial Distribution

  • 00852423006332 ()
N/A

  • Extracorporeal ultrasound imaging transducer, hand-held
Quickscan® Bladder Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
N/A
In Commercial Distribution

  • 00852423006325 ()
QSBU

  • Extracorporeal ultrasound imaging transducer, hand-held
Morpheus® Control Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
N/A
Not in Commercial Distribution

  • 00852423006318 ()
N/A

  • Ultrasonic lithotripsy system
  • Ultrasonic lithotripsy system probe, reusable
Uroflowmetry Load Cell
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
ULC
Not in Commercial Distribution

  • 00852423006301 ()
WLC

  • Urine flowmeter, reusable
Adapter for 7400 Disposable Lead Wire Electrodes
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
7100
In Commercial Distribution

  • 00852423006240 ()
7100

  • Kinesiology/electromyographic sensor set
Pathway® Adapter
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
3660
In Commercial Distribution

  • 00852423006233 ()
3660

  • Biofeedback system
6’ Electrode Lead Wire Set
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
5338
In Commercial Distribution

  • 00852423006226 ()
5338

  • Kinesiology/electromyographic sensor set
24” Electrode Lead Wire Set
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
5328
In Commercial Distribution

  • 00852423006219 ()
5328

  • Biofeedback system
Pathway® 6320 Vaginal/Rectal EMG Sensor
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
6320
In Commercial Distribution

  • 00852423006202 ()
6320

  • Perineometer
Pathway® Rectal Silicon Pressure Sensor
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
6425
In Commercial Distribution

  • 00852423006196 ()
6425

  • Perineometer
Pathway® 6340 Rectal EMG/Stimulation Sensor
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
6340
In Commercial Distribution

  • 00852423006189 ()
6340

  • Perineal orifice incontinence-control electrical stimulation system probe, single-use
  • Perineometer
Pathway® 6330 Vaginal EMG/Stimulation Sensor
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
6330
In Commercial Distribution

  • 00852423006172 ()
6330

  • Perineometer
  • Perineal orifice incontinence-control electrical stimulation system probe, single-use
Pathway® STM-10
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
STM-10
In Commercial Distribution

  • 00852423006165 ()
STM-10

  • Perineal orifice incontinence-control electrical stimulation system, home-use
Pathway® TR-20C Dual Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-20C
In Commercial Distribution

  • 00852423006158 ()
8625

  • Psychophysiological biofeedback system
Pathway® TR-20 Dual Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-20
In Commercial Distribution

  • 00852423006141 ()
8620

  • Psychophysiological biofeedback system
Pathway® TR-10C Single Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-10C
In Commercial Distribution

  • 00852423006134 ()
8615

  • Kinesiology/electromyographic sensor set
Pathway® TR-10 Single Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-10
In Commercial Distribution

  • 00852423006127 ()
8610

  • Psychophysiological biofeedback system
Pathway® NMR 400 Quad Channel EMG System
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
NMR400
In Commercial Distribution

  • 00852423006110 ()
NMR400

  • Perineometer
Synergy® 3-Dimensional Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9225
In Commercial Distribution

  • 00852423006103 ()
9225

  • Biofeedback system application software
Primus® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9275
In Commercial Distribution

  • 00852423006097 ()
9275

  • Biofeedback system application software
Telesis® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250
In Commercial Distribution

  • 00852423006080 ()
9250

  • Biofeedback system application software
Pathway® MR-10 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-10
In Commercial Distribution

  • 00852423006073 ()
9700

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® MR-15 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-15
In Commercial Distribution

  • 00852423006066 ()
9715

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® MR-20 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-20
In Commercial Distribution

  • 00852423006059 ()
9710

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® MR-25 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-25
In Commercial Distribution

  • 00852423006042 ()
9725

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® DUO for Pediatric Voiding Dysfunction
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
PDUO
In Commercial Distribution

  • 00852423006035 ()
PDUO

  • Urine monitoring system monitor
  • Urine monitoring system sensor
  • Urine monitoring system
  • Urine flowmeter, reusable
Pathway® CTS 1500
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS1500
In Commercial Distribution

  • 00852423006028 ()
CTS1500

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution

  • 00852423006011 ()
CTS2000

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
Morpheus® Control Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MOR0118
In Commercial Distribution

  • 00852423006004 ()
MOR0118

  • Ultrasound imaging system operator console
  • Radiology DICOM image processing application software
  • Urodynamic measurement system
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