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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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Spacelabs Healthcare - 10841522111921

HearTwave II
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
In Commercial Distribution

  • 10841522111921 ()
N/A

  • Cardiac stress exercise monitoring system

Sentinel - 10841522106521

PATHFINDER SL HOLTER ANALYSER (ENGLISH) KIT
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522106521 ()
98000-01 KIT

  • Electrocardiographic long-term ambulatory recording analyser

PathfinderSL; SENTINEL - 10841522103209

UPGRADE: CNAV+ TO PATHFINDER SL, SENTINEL10
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200; NAVPLUS
Not in Commercial Distribution

  • 10841522103209 ()
043-0129-00

  • Electrocardiographic long-term ambulatory recording analyser

PATHFINDER SL, SENTINEL10 - 10841522103193

UPGRADE: PA-DIGITAL TO PATHFINDER SL, SENTINEL10
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200, PATHFIND
Not in Commercial Distribution

  • 10841522103193 ()
043-0128-00

  • Electrocardiographic long-term ambulatory recording analyser

PathfinderSL - 10841522103087

SENTINEL 10 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522103087 ()
040-1708-00

  • Electrocardiographic long-term ambulatory recording analyser

Intesys Clinical Suite - 10841522100116

SMART DISCLOSURE,92810
SPACELABS HEALTHCARE (WASHINGTON), INC
92810
Not in Commercial Distribution

  • 10841522100116 ()
V5.2.3

  • Medical equipment clinical data interfacing software

Holter Analysis Software - M581NEMK1630

Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system

MDU5 PLUS - 08714729842309

Motordrive Unit
BOSTON SCIENTIFIC CORPORATION
H749MDU5PLUSR0
In Commercial Distribution

  • 08714729842309 ()


  • Cardiovascular ultrasound imaging system

MDU5 PLUS - 08714729842279

Motordrive Unit
BOSTON SCIENTIFIC CORPORATION
H749MDU5PLUS0
In Commercial Distribution

  • 08714729842279 ()


  • Cardiovascular ultrasound imaging system

Rhythmia™ Mapping System - 08714729842118

Rhythmia Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40000
In Commercial Distribution

  • 08714729842118 ()


  • Cardiac mapping system
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