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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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No Description
Biosense Webster Inc
CR3425CT
In Commercial Distribution

  • 10846835003857 ()
CR3425CT

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CG2025CT
In Commercial Distribution

  • 10846835003826 ()
CG2025CT

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CB3434CT
In Commercial Distribution

  • 10846835003802 ()
CB3434CT

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CB3412CT
In Commercial Distribution

  • 10846835003796 ()
CB3412CT

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
CB3410CT
In Commercial Distribution

  • 10846835003789 ()
CB3410CT

  • Electrical-only medical device connection cable, reusable
CARTO 3 System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG540000
In Commercial Distribution

  • 10846835000870 ()
FG-5400-00

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

  • 10841522130922 ()
040-1724-01

  • Cardiology information system application software
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
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
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
HearTwave II
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
In Commercial Distribution

  • 10841522111921 ()
N/A

  • Cardiac stress exercise monitoring system
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
SMART DISCLOSURE,92810
SPACELABS HEALTHCARE (WASHINGTON), INC
92810
Not in Commercial Distribution

  • 10841522100116 ()
V5.2.3

  • Medical equipment clinical data interfacing software
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
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
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
PATHFINDER SL ANALYSER
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522129537 ()
98000SL

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL V11.X UPGRADE
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129506 ()
040-5172-00

  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129438 ()
040-1708-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 RDT TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129414 ()
040-1725-01

  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT DE
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129407 ()
040-1756-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT DN
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
Not in Commercial Distribution

  • 10841522129391 ()
040-1755-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT NL
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129384 ()
040-1754-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT BR-PT
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129377 ()
040-1753-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT PL
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129360 ()
040-1752-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT SV
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129353 ()
040-1751-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT ES
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129346 ()
040-1750-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT IT
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129339 ()
040-1749-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
PATHFINDER SL/SENTINEL 11 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129322 ()
040-1726-02

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT FR
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129315 ()
040-1748-01

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