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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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Welch Allyn, Inc. - 00732094264340

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

  • 00732094264340 ()
H3PLUS-CBD-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264333

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

  • 00732094264333 ()
H3PLUS-CBE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264326

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

  • 00732094264326 ()
H3PLUS-CCB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264319

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

  • 00732094264319 ()
H3PLUS-CCE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264302

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

  • 00732094264302 ()
H3PLUS-CDB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264296

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

  • 00732094264296 ()
H3PLUS-CDE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264289

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

  • 00732094264289 ()
H3PLUS-CEB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264272

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

  • 00732094264272 ()
H3PLUS-CEE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264265

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

  • 00732094264265 ()
H3PLUS-CFB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264258

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

  • 00732094264258 ()
H3PLUS-CFE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264241

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

  • 00732094264241 ()
H3PLUS-CGB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264234

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

  • 00732094264234 ()
H3PLUS-CHA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264227

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

  • 00732094264227 ()
H3PLUS-CHB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264210

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

  • 00732094264210 ()
H3PLUS-CHD-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264203

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

  • 00732094264203 ()
H3PLUS-CHE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264197

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

  • 00732094264197 ()
H3PLUS-CJE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264180

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

  • 00732094264180 ()
H3PLUS-CLB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264173

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

  • 00732094264173 ()
H3PLUS-CLE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264166

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

Welch Allyn, Inc. - 00732094264159

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

Welch Allyn, Inc. - 00732094264142

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

Welch Allyn, Inc. - 00732094264135

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

ORLocate - 00724995220679

Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.
Steris Corporation
ORLocate Tablet
Not in Commercial Distribution

  • 00724995220679 ()
OX216

  • Electronic surgical sponge-counter

Welch Allyn, Inc. - 00732094212464

TAGCONNECT SOFTWARE AND SMART CABLE
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094212464 ()
TAGECG-SW

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094257786

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

  • 00732094257786 ()
H3PLUS-CAA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094246896

TAGECG WEARABLE SENSOR
WELCH ALLYN, INC.
901098
In Commercial Distribution

  • 00732094212471 ()
  • 00732094246896 ()
TAGECG-1

  • 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 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

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

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

CONTEC - 06945040101499

Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5007
In Commercial Distribution

  • 06945040101499 ()


  • Electrocardiographic ambulatory recorder

CONTEC - 06945040101406

Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC6000
In Commercial Distribution

  • 06945040101406 ()


  • Electrocardiographic ambulatory recorder

CONTEC - 06945040100294

Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5000
In Commercial Distribution

  • 06945040100294 ()


  • Electrocardiographic ambulatory recorder

TR6 recorder(TR6F) - 06944904086415

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-032908-00
In Commercial Distribution

  • 06944904086415 ()


  • Patient monitoring system module, printing
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