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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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WA Holter System - 90815187020290

HR300 Mini Holter Recorder Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020290 ()
404955

  • Electrocardiographic ambulatory recorder

TranS1 - 00815361020297

AxiaLIF Plus Exchange System Fixation Wire
QUANDARY MEDICAL LLC
TR1-2212
In Commercial Distribution

  • 00815361020297 ()


  • Orthopaedic bone wire

HydroMax HMEF - 00817081026719

HydroMax, Disposable, Heat and Moisture Exchange
A-M SYSTEMS, LLC
HydroMax HMEF - 158250
In Commercial Distribution

  • 00817081026726 ()
  • 00817081026719 ()
158250

  • Heat/moisture exchanger/microbial medical gas filter

Scanner S300 - D800ERAB4061

Scanner S300 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4061
In Commercial Distribution

  • D800ERAB4061 ()


  • Dental milling system, CAD/CAM, laboratory

Scanner S900 - D800ERAB4051

Scanner S900 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4051
In Commercial Distribution

  • D800ERAB4051 ()


  • Dental milling system, CAD/CAM, laboratory

Welch Allyn, Inc. - 00732094009125

PROBP 3400 STANDARD W SUREBP EXCHANGE
WELCH ALLYN, INC.
901055
In Commercial Distribution

  • 00732094009125 ()
34XF-EX

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

NA - 00763000123741

CUSTOM PACK CB10M30R OXY EXCHANGE P
MEDTRONIC, INC.
CB10M30R
In Commercial Distribution

  • 00763000123741 ()


  • Cardiopulmonary bypass system blood tubing set

Xper Flex Cardio Physiomonitoring System - 00884838095069

Xper FC2010 REV E Russian Exchange
Philips Ds North America LLC
Xper FC2010 REV E Russian Exchange
In Commercial Distribution

  • 00884838095069 ()
453564845881

  • General-purpose multi-parameter bedside monitor

Xper Flex Cardio Physiomonitoring System - 00884838091498

Xper FC2010 Rev D Russia Exchange
Philips Ds North America LLC
Xper FC2010 Rev D Russia Exchange
Not in Commercial Distribution

  • 00884838091498 ()
453564674581

  • General-purpose multi-parameter bedside monitor

Merit Laureate® - 00884450236208

No Description
Merit Medical Systems, Inc.
00884450236208
In Commercial Distribution

  • 10884450236205 ()
  • 00884450236208 ()
  • 20884450236202 ()

  • Tip Shape-Straight Tip
  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Configuration-Standard Exchange; Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
  • Length-260 cm (102"); Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
LWSTDS35260EX/D

  • Peripheral vascular guidewire, manual
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