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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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DigiTrak XT - 00884838000476

DigiTrak XT Holter Recorder
Philips Medical Systems Hsg
DigiTrak XT Holter Recorder
In Commercial Distribution

  • 00884838000476 ()
860322

  • Electrocardiographic ambulatory recorder

Holter Software - 00884838000469

No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838000469 ()
860292

  • 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

DelWorks - 00858340006097

PORTABLE WORKSTATION Wirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistance The DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.
Del Medical, Inc.
3.0
In Commercial Distribution

  • 00858340006097 ()


  • Diagnostic x-ray digital imaging system workstation

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

Chroma 7 Lead Patient Cable - 00856298006312

7 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100608
In Commercial Distribution

  • 00856298006312 ()


  • Electrocardiographic ambulatory recorder

Chroma 5 Lead Patient Cable - 00856298006220

5 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100605
In Commercial Distribution

  • 00856298006220 ()


  • Electrocardiographic ambulatory recorder

Chroma2 - 00856298006015

No Description
SCOTTCARE CORPORATION, THE
RZ153C2
In Commercial Distribution

  • 00856298006015 ()
101942

  • Electrocardiographic ambulatory recorder

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

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
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