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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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VX3+ - 00851074007019

Holter Recorder
DATRIX LLC
VX3+ Series M
In Commercial Distribution

  • 00851074007019 ()


  • 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

IMAGE DIAGNOSTICS INC - 00850977007713

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 32IN. MONITOR,FIXED,MONITOR CART,IDI W/HD MONITOR,#A280-0630
IMAGE DIAGNOSTICS, INC.
MONITOR CART,IDI W/HD MONITOR
In Commercial Distribution

  • 00850977007713 ()
A280-0630

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007676

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR W/1X VIDEO INPUT,TELESCOPIC,ILEX D,120V-230V,#A280-1143
IMAGE DIAGNOSTICS, INC.
ilex D,1X INPUT 55IN. MONITOR
In Commercial Distribution

  • 00850977007676 ()
A280-1143

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007669

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR W/4X VIDEO INPUT,TELESCOPIC,ILEX D,120V-230V,#A280-1069
IMAGE DIAGNOSTICS, INC.
ilex D,4X INPUT 55IN. MONITOR
In Commercial Distribution

  • 00850977007669 ()
A280-1069

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007645

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/MSV2,120V,#A280-0980
IMAGE DIAGNOSTICS, INC.
ilex55 W/MSV2, 120V
In Commercial Distribution

  • 00850977007645 ()
A280-0980

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007638

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 58IN. MONITOR,TELESCOPIC,ILEX W/MSV2,120V,#A280-0981
IMAGE DIAGNOSTICS, INC.
ilex58 W/MSV2, 120V
In Commercial Distribution

  • 00850977007638 ()
A280-0981

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850977007461

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 26IN. MONITORS,PREVIEW DISPLAY,MDS,120V,#A280-0330
IMAGE DIAGNOSTICS, INC.
MDS, 120V
Not in Commercial Distribution

  • 00850977007461 ()
A280-0330

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS INC - 00850977007454

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 32IN. MONITOR,FIXED,ILEX32,#A280-0630 OR #A280-0821 FOR THE 4K VERSION
IMAGE DIAGNOSTICS, INC.
ilex32
In Commercial Distribution

  • 00850977007454 ()
A280-0630 & A280-0821

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007447

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/IPS500A,230V,#A280-0781
IMAGE DIAGNOSTICS, INC.
ilex55, 230V
In Commercial Distribution

  • 00850977007447 ()
A280-0781

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007430

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/IPS500A,120V,#A280-0600 OR W/IPS1000A #A280-0700
IMAGE DIAGNOSTICS, INC.
ilex55, 120V
In Commercial Distribution

  • 00850977007430 ()
A280-0600 OR A280-0700

  • Diagnostic x-ray digital imaging system workstation

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

mcompass Anorectal Manometry System - 00851607003396

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

  • 10851607003393 ()
  • 00851607003396 ()


  • 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

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

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

  • 00851607003297 ()


  • 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

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, 60cc, 5-pack - 00851607003266

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

  • 00851607003266 ()
  • 10851607003263 ()


  • 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

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

Commode - 00851607003228

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

  • 00851607003228 ()
  • 10851607003225 ()


  • Manometric gastrointestinal motility analysis system
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