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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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H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Czech language and CD manual; IEC 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264166 ()
H3PLUS-CMB-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Czech language and CD manual; IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264159 ()
H3PLUS-CME-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Brazilian Portugese INMETRO labeling, language, and CD manual; IEC 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264142 ()
H3PLUS-COB-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); English language, no manual; IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264135 ()
H3PLUS-CZE-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Brazilian Portugese INMETRO labeling, language, and CD manual; AHA 5 wire, 15" (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094308563 ()
H3PLUS-COD-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Brazilian Portugese INMETRO labeling, language, and CD manual; IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094308556 ()
H3PLUS-COE-XXXXX

  • Electrocardiographic ambulatory recorder
DigiTrak XT Holter Recorder
Philips Medical Systems Hsg
DigiTrak XT Holter Recorder
In Commercial Distribution

  • 00884838000476 ()
860322

  • Electrocardiographic ambulatory recorder
No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838000469 ()
860292

  • Electrocardiographic ambulatory recorder
Blue LED Light for the treatment of acne
PULSADERM LLC
PD9700R
In Commercial Distribution

  • 00858830007764 ()


  • Red/blue light phototherapy unit
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
Blue LED Light for the treatment of acne
PULSADERM LLC
PD9700
In Commercial Distribution

  • 00858830007047 ()


  • Red/blue light phototherapy unit
7 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100608
In Commercial Distribution

  • 00856298006312 ()


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

  • 00856298006220 ()


  • Electrocardiographic ambulatory recorder
No Description
SCOTTCARE CORPORATION, THE
RZ153C2
In Commercial Distribution

  • 00856298006015 ()
101942

  • Electrocardiographic ambulatory recorder
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
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
IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 32IN. 4K MONITORS WITH RECORDER,ILEX DUO,120V,#A280-1569
IMAGE DIAGNOSTICS, INC.
ILEX DUO PLATINUM 32
In Commercial Distribution

  • 00850061871282 ()
A280-1569

  • Diagnostic x-ray digital imaging system workstation
IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 32IN. 4K MONITORS,ILEX DUO,120V,#A280-1568
IMAGE DIAGNOSTICS, INC.
ILEX DUO DIRECT PREMIUM 32
In Commercial Distribution

  • 00850061871275 ()
A280-1568

  • Diagnostic x-ray digital imaging system workstation
IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 27IN. 4K MONITORS,ILEX DUO,120V,#A280-1567
IMAGE DIAGNOSTICS, INC.
ILEX DUO DIRECT CONNECT 27
In Commercial Distribution

  • 00850061871268 ()
A280-1567

  • Diagnostic x-ray digital imaging system workstation
LS Pro Systems Face Pad in Silicone 122 blue/red/ LED flexi-pad. Intended to emit both red and blue light for the treatment of a facial skin conditions and help with mood, circadian rhythm, sleep, and relaxation. It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin. Promotes circulation at the skin level and can increase elasticity/collagen. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
F122-SI
In Commercial Distribution

  • 00850061407214 ()


  • Red/blue light phototherapy unit
LS Pro Systems Face Pad 104 blue/red/ LED flexi-pad. Intended to emit both red and blue light for the treatment of a facial skin conditions and help with mood, circadian rhythm, sleep, and relaxation. It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin. Promotes circulation at the skin level and can increase elasticity/collagen. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
F104
In Commercial Distribution

  • 00850061407085 ()


  • Red/blue light phototherapy unit
ECG Recorder
DATRIX LLC
VX3+ Series T
In Commercial Distribution

  • 00851074007361 ()
VX3+ Series T

  • Electrocardiographic ambulatory recorder
ECG Recorder
DATRIX LLC
VX3+ Series L
In Commercial Distribution

  • 00851074007316 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
DATRIX LLC
VX3+ Series H
In Commercial Distribution

  • 00851074007156 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
DATRIX LLC
VX3+ Series Hatco
In Commercial Distribution

  • 00851074007095 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
DATRIX LLC
VX3+ Series CDM
In Commercial Distribution

  • 00851074007064 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
DATRIX LLC
VX3+ Series C
In Commercial Distribution

  • 00851074007057 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
DATRIX LLC
VX3+ Series A
In Commercial Distribution

  • 00851074007040 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
DATRIX LLC
VX3+ Series R
In Commercial Distribution

  • 00851074007033 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
DATRIX LLC
VX3+ Series P
In Commercial Distribution

  • 00851074007026 ()


  • Electrocardiographic ambulatory recorder
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