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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, BROWN. 10PK
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY; ARIA
Not in Commercial Distribution

  • 10841522118456 ()
700-0369-00

  • Electrocardiographic lead set, reusable
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
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
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