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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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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 - 10841522103315

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

  • 10841522103315 ()
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

Spacelabs Healthcare - 10841522103292

BATTERY,LITHIUM, FOR SL6 / SL6A
SPACELABS HEALTHCARE (WASHINGTON), INC
98400
Not in Commercial Distribution

  • 10841522103292 ()
N/A

  • Portable/mobile rechargeable battery pack

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 - 10841522103131

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103131 ()
040-1713-00

  • Cardiology information system application software

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 - 10841522103117

SENTINEL 10 WORKSTATION (X5) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103117 ()
040-1711-00

  • Cardiology information system application software

Sentinel - 10841522103100

SENTINEL 10 WORKSTATION (X2) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103100 ()
040-1710-00

  • 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

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

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

Blease - 10841522102967

FIELD UPGRADE ABSORBER LOCK
SPACELABS HEALTHCARE (WASHINGTON), INC
SIRIUS
Not in Commercial Distribution

  • 10841522102967 ()
N/A

  • Anaesthesia unit, mobile

Spacelabs Healthcare - 10841522102868

KIT, MULTI-BAND, W/PS, PLEN, ACT ANT,ADC
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
In Commercial Distribution

  • 10841522102868 ()
040-1428-03

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102844

KIT,TM MOD,MV2 TO MV2 ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102844 ()
3.05.07EN

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102837

KIT,TM MOD,MV1 ST TO MV2 ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102837 ()
3.05.07EN

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102813

KIT,TM MOD,MV1 TO MV2
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102813 ()
3.05.07EN

  • Electrocardiography monitoring system receiver
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