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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. - 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. - 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

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

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

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

mcompass Anorectal Manometry System - 00851607003396

mcompass Anorectal Manometry System
MEDSPIRA, LLC
RMD-001U
In Commercial Distribution

  • 10851607003393 ()
  • 00851607003396 ()


  • Manometric gastrointestinal motility analysis system

Syringe, Luer, 200cc, 5-pack - 00851607003297

No Description
MEDSPIRA, LLC
RMD-010-008
In Commercial Distribution

  • 00851607003297 ()


  • Manometric gastrointestinal motility analysis system

mcompass ARM and BIofeedback System - 00851607003273

Medspira Anorectal Manometry and Biofeedback System
MEDSPIRA, LLC
RMD-003
In Commercial Distribution

  • 00851607003273 ()
  • 10851607003270 ()


  • Manometric gastrointestinal motility analysis system

Syringe, Luer, 5cc, 5-pack - 00851607003259

No Description
MEDSPIRA, LLC
RMD-010-006
In Commercial Distribution

  • 00851607003259 ()
  • 10851607003256 ()


  • Manometric gastrointestinal motility analysis system

Commode - 00851607003228

No Description
MEDSPIRA, LLC
RMD-002-COM
In Commercial Distribution

  • 00851607003228 ()
  • 10851607003225 ()


  • Manometric gastrointestinal motility analysis system

5-Pack, Luer-Locking, 100cc Syringe - 00851607003532

100cc Syringe, Luer-Locking, 5-Pack
MEDSPIRA, LLC
RMD-010-017
In Commercial Distribution

  • 10851607003539 ()
  • 00851607003532 ()


  • Manometric gastrointestinal motility analysis system

Battery, Tablet PC - 00851607003525

Battery for Tablet PC
MEDSPIRA, LLC
RMD-010-009
In Commercial Distribution

  • 00851607003525 ()
  • 10851607003522 ()


  • Manometric gastrointestinal motility analysis system

5-Pack, 100 cc Syringe, Luer-locking - 00851607003518

Syringe, Luer-Locking, 100cc, 5-Pack
MEDSPIRA, LLC
RMD-010-016
In Commercial Distribution

  • 10851607003515 ()
  • 00851607003518 ()


  • Manometric gastrointestinal motility analysis system

AC Power Cable - 00851607003495

AC Power Cable, 3-Prong, US
MEDSPIRA, LLC
RMD-010-003
In Commercial Distribution

  • 10851607003492 ()
  • 00851607003495 ()


  • Manometric gastrointestinal motility analysis system

System Accessory Kit - 00851607003389

Accessories for mcompass systems
MEDSPIRA, LLC
RMD-010-011
In Commercial Distribution

  • 10851607003386 ()
  • 00851607003389 ()


  • Manometric gastrointestinal motility analysis system

Medspira Tablet PC with Power Supply - 00851607003372

Medspira Tablet PC with Power Supply
MEDSPIRA, LLC
RMD-010-010
In Commercial Distribution

  • 10851607003379 ()
  • 00851607003372 ()


  • Manometric gastrointestinal motility analysis system

Battery, FOB - 00851607003365

Battery for FOB
MEDSPIRA, LLC
RMD-010-009
In Commercial Distribution

  • 10851607003362 ()
  • 00851607003365 ()


  • Manometric gastrointestinal motility analysis system

Medspira mcompass Anorectal Manometry Dock for Tablet PC, w/Power Supply - 00851607003310

No Description
MEDSPIRA, LLC
RMD-010-004
In Commercial Distribution

  • 10851607003317 ()
  • 00851607003310 ()


  • Manometric gastrointestinal motility analysis system

Medspira mcompass Anorectal Manometry Tablet PC, w Dock, w Power Cord - 00851607003280

No Description
MEDSPIRA, LLC
RMD-001-TAB
In Commercial Distribution

  • 00851607003280 ()
  • 10851607003287 ()


  • Manometric gastrointestinal motility analysis system

Syringe, Luer, 60cc, 5-pack - 00851607003266

No Description
MEDSPIRA, LLC
RMD-010-007
In Commercial Distribution

  • 00851607003266 ()
  • 10851607003263 ()


  • Manometric gastrointestinal motility analysis system

Syringe, Luer, 140cc, 5-pack - 00851607003242

No Description
MEDSPIRA, LLC
RMD-010-005
In Commercial Distribution

  • 00851607003242 ()
  • 10851607003249 ()


  • Manometric gastrointestinal motility analysis system

LED Monitor - 00851607003235

No Description
MEDSPIRA, LLC
RMD-002-MON
In Commercial Distribution

  • 00851607003235 ()
  • 10851607003232 ()


  • Manometric gastrointestinal motility analysis system

mcompass Biofeedback Manometry Software - 00851607003211

No Description
MEDSPIRA, LLC
RMD-002-001
In Commercial Distribution

  • 00851607003211 ()


  • Manometric gastrointestinal motility analysis system

mcompass Anorectal Manometry Software - 00851607003204

No Description
MEDSPIRA, LLC
RMD-001-003
In Commercial Distribution

  • 00851607003204 ()


  • Manometric gastrointestinal motility analysis system

VGA Cable - 00851607003174

No Description
MEDSPIRA, LLC
RMD-002-VGA
In Commercial Distribution

  • 00851607003174 ()
  • 10851607003171 ()


  • Manometric gastrointestinal motility analysis system

Switch, Inline Flow Control, Female Luer Inlet, Male Luer Outlet, 5-pack - 00851607003143

No Description
MEDSPIRA, LLC
RMD-010-001
In Commercial Distribution

  • 00851607003143 ()


  • Manometric gastrointestinal motility analysis system

Pouch with Strap for mcompass® FOB - 00851607003099

No Description
MEDSPIRA, LLC
RMD-002-POUCH
In Commercial Distribution

  • 00851607003099 ()
  • 10851607003096 ()


  • Manometric gastrointestinal motility analysis system

mcompass Biofeedback Manometry System - 00851607003068

Medspira Biofeedback Anorectal Manometry System
MEDSPIRA, LLC
RMD-002
In Commercial Distribution

  • 10851607003065 ()
  • 00851607003068 ()
RMD-002

  • Manometric gastrointestinal motility analysis system

mcompass Anorectal Manometry System - 00851607003051

Medspira mcompass Diagnostic Anorectal Manometry system
MEDSPIRA, LLC
RMD-001
In Commercial Distribution

  • 10851607003058 ()
  • 00851607003051 ()
RMD-001

  • Manometric gastrointestinal motility analysis system

mcompass Anorectal Manometry FOB - 00851607003044

Medspira mcompass Anorectal Manometry FOB
MEDSPIRA, LLC
RMD-001-001
In Commercial Distribution

  • 00851607003044 ()
  • 10851607003041 ()
RMD-001-001

  • Manometric gastrointestinal motility analysis system
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