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

  • 10841522118449 ()
700-0368-00

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

  • 10841522118432 ()
700-0367-00

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

  • 10841522118425 ()
700-0366-00

  • Electrocardiographic lead set, reusable
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
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
SMART DISCLOSURE,92810
SPACELABS HEALTHCARE (WASHINGTON), INC
92810
Not in Commercial Distribution

  • 10841522100116 ()
V5.2.3

  • Medical equipment clinical data interfacing software
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
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
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
No Description
Implicity Inc.
V1.1.4
In Commercial Distribution

  • 03770025266008 ()
IM007

  • Cardiology information system application software
EGM Out to Signal Station Cable (IBI™)
BOSTON SCIENTIFIC CORPORATION
M004RA61020
In Commercial Distribution

  • 08714729971306 ()
M004RA61020

  • Electrical-only medical device connection cable, reusable
EGM Out to Signal Station Cable (Stockert™)
BOSTON SCIENTIFIC CORPORATION
M004RA60020
In Commercial Distribution

  • 08714729971290 ()
M004RA60020

  • Electrical-only medical device connection cable, reusable
Signal Station
BOSTON SCIENTIFIC CORPORATION
M004RH1020R0
In Commercial Distribution

  • 08714729965879 ()


  • Transducer signal amplifier
Signal Station
BOSTON SCIENTIFIC CORPORATION
M004RH1020H0
In Commercial Distribution

  • 08714729965862 ()


  • Transducer signal amplifier
Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBEVAL2END0
In Commercial Distribution

  • 08714729960096 ()


  • Cardiac mapping system
Signal Station Kit
BOSTON SCIENTIFIC CORPORATION
M004RH1000R0
In Commercial Distribution

  • 08714729952862 ()


  • Transducer signal amplifier
Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40100
In Commercial Distribution

  • 08714729948407 ()
M004RH40100

  • Cardiac mapping system
Foot Switch
BOSTON SCIENTIFIC CORPORATION
M004RH15010
In Commercial Distribution

  • 08714729948384 ()
M004RH15010

  • Foot-switch, electrical
Integrated System
BOSTON SCIENTIFIC CORPORATION
H74939322120I0
In Commercial Distribution

  • 08714729946137 ()


  • Cardiovascular ultrasound imaging system
Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120CR0
In Commercial Distribution

  • 08714729946120 ()


  • Cardiovascular ultrasound imaging system
Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120CD0
In Commercial Distribution

  • 08714729946113 ()


  • Cardiovascular ultrasound imaging system
Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120C0
In Commercial Distribution

  • 08714729946106 ()


  • Cardiovascular ultrasound imaging system
Connecting Cable, Cable Adapter
BOSTON SCIENTIFIC CORPORATION
H7495553710
In Commercial Distribution

  • 08714729940425 ()


  • Cardiovascular ultrasound imaging system
FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H749555100R0
In Commercial Distribution

  • 08714729939603 ()


  • Cardiovascular ultrasound imaging system
FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H749555100H0
In Commercial Distribution

  • 08714729939597 ()


  • Cardiovascular ultrasound imaging system
Localization Generator
BOSTON SCIENTIFIC CORPORATION
M004RH20010
In Commercial Distribution

  • 08714729938736 ()
M004RH20010

  • Electromagnetic surgical navigation device tracking system
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