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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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VMA Motion Normalizer - 00868579000247

VMA Motion Normalizer (Console, Table, and Upright assemblies)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000247 ()


  • Diagnostic x-ray digital imaging system workstation

VMA - 00868579000209

No Description
ORTHO KINEMATICS, INC.
2
In Commercial Distribution

  • 00868579000209 ()


  • Diagnostic x-ray digital imaging system workstation

myPatch® - 00857522005019

3 channel Holter recorder
DMS-SERVICE LLC
s
In Commercial Distribution

  • 00857522005019 ()

  • Length: 40 Millimeter
  • Depth: 10 Millimeter
  • Width: 49 Millimeter
mp3

  • Electrocardiographic ambulatory recorder

Messenger - 00860011811961

Messenger 6.1.1 Software Release
SPOK INC.
6.1.0
In Commercial Distribution

  • 00860011811961 ()


  • Alarm application software

Messenger - 00860011811954

Messenger 5.18.4 Software Release
SPOK INC.
5.18.4
In Commercial Distribution

  • 00860011811954 ()


  • Alarm application software

Messenger - 00860011811947

Messenger 5.17.17 Software Release
SPOK INC.
5.17.17
In Commercial Distribution

  • 00860011811947 ()


  • Alarm application software

Messenger - 00860011811930

Messenger 5.18.3 Software Release
SPOK INC.
5.18.3
In Commercial Distribution

  • 00860011811930 ()


  • Alarm application software

Messenger - 00860011811923

Messenger 6.1.0 Software Release
SPOK INC.
6.1.0
In Commercial Distribution

  • 00860011811923 ()


  • Alarm application software

Messenger - 00860011811916

Messenger 5.18.2 Software Release
SPOK INC.
5.18.2
In Commercial Distribution

  • 00860011811916 ()


  • Alarm application software

Messenger - 00860011811909

Messenger 5.17.16 Software Release
SPOK INC.
5.17.16
In Commercial Distribution

  • 00860011811909 ()


  • Alarm application software

Mui Scientific - 00678467000071

3 Channel Compressed Air SOM Pump
H & A Mui Enterprises Inc
PIP-5-3SS
Not in Commercial Distribution

  • 00678467000071 ()


  • Manometric gastrointestinal motility analysis system

Mui Scientific - 00678467000040

12 Channel Compressed Air Manometric Pump
H & A Mui Enterprises Inc
PIP-4-12SS
Not in Commercial Distribution

  • 00678467000040 ()


  • Manometric gastrointestinal motility analysis system

Mui Scientific - 00678467000033

8 Channel Compressed Air Manometric Pump
H & A Mui Enterprises Inc
PIP-4-8SS
Not in Commercial Distribution

  • 00678467000033 ()


  • Manometric gastrointestinal motility analysis system

Mui Scientific - 00678467000026

6 Channel Compressed Air Manometric Pump
H & A Mui Enterprises Inc
PIP-4-6SS
Not in Commercial Distribution

  • 00678467000026 ()


  • Manometric gastrointestinal motility analysis system

Mui Scientific - 00678467000019

4 Channel Compressed Air Manometric Pump
H & A Mui Enterprises Inc
PIP-4-4SS
Not in Commercial Distribution

  • 00678467000019 ()


  • Manometric gastrointestinal motility analysis system

Chroma - 00856298006008

The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) continuous recording of ambulatory electrocardiograph (AECG) data on a single AAA battery. It has the ability to detect and record pacemaker pulses according to the appropriate criteria for Association for the Advancement of Medical Instrumentation (AAMI) pacer detection.
SCOTTCARE CORPORATION, THE
RZ153C
In Commercial Distribution

  • 00856298006008 ()
101273

  • Electrocardiographic ambulatory recorder

Pulsaderm - 00858830007764

Blue LED Light for the treatment of acne
PULSADERM LLC
PD9700R
In Commercial Distribution

  • 00858830007764 ()


  • Red/blue light phototherapy unit

LED Blue Acne Clearing Mask - 00858830007047

Blue LED Light for the treatment of acne
PULSADERM LLC
PD9700
In Commercial Distribution

  • 00858830007047 ()


  • Red/blue light phototherapy unit

Q Patch Downloader - 05903021560162

Q Patch Downloader (PC application) – The intended use of the Q Patch Downloader application is to download the data from completed Q Patch session and upload files containing ECG data to the predefine storage space.
MEDICALGORITHMICS S A
9.48
In Commercial Distribution

  • 05903021560162 ()


  • Electrocardiographic ambulatory recorder

Q Patch Mobile Application - 05903021560155

Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with the Q Patch recorder for transmission patient data to set up ECG recording session and displaying the Q Patch’s status. The application is obligatory for healthcare professionals and optional for patients
MEDICALGORITHMICS S A
1.0
In Commercial Distribution

  • 05903021560155 ()


  • Electrocardiographic ambulatory recorder

Q Patch - 05903021560124

The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient’s ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch’s memory can be downloaded through a USB port using the Q Patch Downloader (PC application).
MEDICALGORITHMICS S A
P5HP-AA-ADS
In Commercial Distribution

  • 05903021560124 ()


  • Electrocardiographic ambulatory recorder

Omnilux Blemish Eraser - 05060534510807

Omnilux Blemish Eraser- Mini LED Patch to treat mild to moderate acne vulgaris
I-SMART DEVELOPMENTS LIMITED
TN2197
In Commercial Distribution

  • 05060534510807 ()


  • Red/blue light phototherapy unit

Luma Blemish - 05060534510685

Luma Blemish- Mini LED Patch to treat mild to moderate acne vulgaris
I-SMART DEVELOPMENTS LIMITED
TN2197
In Commercial Distribution

  • 05060534510685 ()


  • Red/blue light phototherapy unit

Omnilux CLEAR - 05060534510234

Over-The-Counter Powered Light Based Laser For Acne- Omnilux CLEAR branded
I-SMART DEVELOPMENTS LIMITED
TN2112
In Commercial Distribution

  • 05060534510234 ()
135-OC

  • Red/blue light phototherapy unit

Microlife - 04719003932053

No Description
MICROLIFE USA, INC.
CUFFM-WBPOANKLE
In Commercial Distribution

  • 14719003932050 ()
  • 04719003932053 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 04719003631284

No Description
MICROLIFE USA, INC.
BP3SZ1-1AFIB
In Commercial Distribution

  • 14719003631281 ()
  • 04719003631284 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 04719003315085

WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets
MICROLIFE USA, INC.
CRO-BP3MX1-3C1
In Commercial Distribution

  • 04719003315085 ()
  • 14719003315082 ()
  • 24719003315089 ()
  • 34719003315086 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 04719003315047

WatchBP O3 2G(BP3SZ1-1) CBP type
MICROLIFE USA, INC.
BP3SZ1-1CEN
In Commercial Distribution

  • 14719003315044 ()
  • 04719003315047 ()
  • 24719003315041 ()
WatchBP O3 2G

  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 04719003315030

WatchBP O3 2G(BP3SZ1-1) Advanced type
MICROLIFE USA, INC.
BP3SZ1-1
In Commercial Distribution

  • 14719003315037 ()
  • 04719003315030 ()
  • 24719003315034 ()
WatchBP O3 2G

  • Arrythmia-detection blood pressure ambulatory recorder

Shark - 00622356086912

The CryoGlow is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
SharkNinja Operating LLC
CryoGlow
In Commercial Distribution

  • 00622356086912 ()


  • Red/blue light phototherapy unit

Cerner CareAware Event Management - 00853023006135

No Description
Cerner Corporation
CareAwareEventManagement6
In Commercial Distribution

  • 00853023006135 ()


  • Alarm application software

Cerner CareAware Event Management - 00853023006111

No Description
Cerner Corporation
CareAwareEventManagement5
In Commercial Distribution

  • 00853023006111 ()


  • Alarm application software

Datrix - 00851074007361

ECG Recorder
DATRIX LLC
VX3+ Series T
In Commercial Distribution

  • 00851074007361 ()
VX3+ Series T

  • Electrocardiographic ambulatory recorder

Datrix - 00851074007316

ECG Recorder
DATRIX LLC
VX3+ Series L
In Commercial Distribution

  • 00851074007316 ()


  • Electrocardiographic ambulatory recorder

VX3+ - 00851074007156

Holter Recorder
DATRIX LLC
VX3+ Series H
In Commercial Distribution

  • 00851074007156 ()


  • Electrocardiographic ambulatory recorder

VX3+ - 00851074007057

Holter Recorder
DATRIX LLC
VX3+ Series C
In Commercial Distribution

  • 00851074007057 ()


  • Electrocardiographic ambulatory recorder

BodyGuardian - 00851074007033

Holter Recorder
DATRIX LLC
VX3+ Series R
In Commercial Distribution

  • 00851074007033 ()


  • Electrocardiographic ambulatory recorder

IMAGE DIAGNOSTICS, INC. - 00850977007928

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 27IN. 4K MONITORS,PREVIEW DISPLAY,MDS,120V,#A280-0983
IMAGE DIAGNOSTICS, INC.
MDS, 4K, 120V
In Commercial Distribution

  • 00850977007928 ()
A280-0983

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS INC - 00850977007737

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 27IN. TOUCH SCREEN MONITOR,FIXED,MONITOR CART,#A280-0811
IMAGE DIAGNOSTICS, INC.
MONITOR CART,IDI W/27IN TOUCH SCREEN MONITOR
In Commercial Distribution

  • 00850977007737 ()
A280-0811

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS INC - 00850977007720

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 32IN. MONITOR,FIXED,MONITOR CART,IDI W/4K MONITOR,#A280-0821
IMAGE DIAGNOSTICS, INC.
MONITOR CART,IDI W/4K MONITOR
In Commercial Distribution

  • 00850977007720 ()
A280-0821

  • Diagnostic x-ray digital imaging system workstation
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