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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 - 10841522118449

HOLTER LEADWIRES, EVO/ARIA, ORANGE. 10PK
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY; ARIA
Not in Commercial Distribution

  • 10841522118449 ()
700-0368-00

  • Electrocardiographic lead set, reusable

Spacelabs Healthcare - 10841522118432

HOLTER LEADWIRES, EVO/ARIA, RED. 10PK
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY; ARIA
Not in Commercial Distribution

  • 10841522118432 ()
700-0367-00

  • Electrocardiographic lead set, reusable

Spacelabs Healthcare - 10841522118425

HOLTER LEADWIRES, EVO/ARIA, WHITE. 10PK
SPACELABS HEALTHCARE (WASHINGTON), INC
ARIA; TAY
Not in Commercial Distribution

  • 10841522118425 ()
700-0366-00

  • Electrocardiographic lead set, reusable

Pathfinder SL - 10841522118128

CD ASSY PATHFINDER SL 1.8.0
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522118128 ()
063-2467-00

  • Electrocardiographic long-term ambulatory recording analyser

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

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

SENTINEL - 10841522130922

SENTINEL 11 HL7 TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
In Commercial Distribution

  • 10841522130922 ()
040-1724-01

  • Cardiology information system application software

Lifescreen Pro - 10841522129773

SENTINEL/LIFESCREEN PRO RAPID ANALYSIS KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifescreen Pro
In Commercial Distribution

  • 10841522129773 ()
040-5173-00

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser

Sentinel - 10841522129551

UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129551 ()
040-1766-00

  • Cardiology information system application software
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