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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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Trulink - 10841522103582

Supplies and Accessories
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522103582 ()
  • 00841522103585 ()


  • Electrocardiographic lead set, reusable

Sentinel - 10841522103452

Cardiology Information Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103452 ()
10.0.1

  • Cardiac stress exercise monitoring system

Spacelabs Healthcare - 10841522103322

Evo Holter Recorder, originally Del Mar Reynolds product
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103322 ()
N/A

  • Electrocardiographic lead set, reusable

Spacelabs Healthcare - 10841522103308

Evo Holter Recorder, originally Del Mar Reynolds product
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103308 ()
N/A

  • Electrocardiographic lead set, reusable

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

SENTINEL - 10841522103124

SENTINEL 10 WORKSTATION (X10) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103124 ()
040-1712-00

  • Cardiology information system application software

Sentinel - 10841522103094

SENTINEL 10 WORKSTATION (X1) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103094 ()
040-1709-00

  • Cardiology information system application software

UltraviewSL - 10841522102981

KIT, DM3 UPDATE, V1.8
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102981 ()
V1.8

  • Multiple vital physiological parameter monitoring system, clinical

UltraviewSL - 10841522102974

KIT, DM3 UPDATE, V1.7
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102974 ()
V1.7

  • Multiple vital physiological parameter monitoring system, clinical
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