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 10 / PATHFINDER SL KIT IT
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125669 ()
040-1749-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT DE
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125096 ()
040-1756-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT NL
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125072 ()
040-1754-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT BR-PT
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125065 ()
040-1753-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT SV
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125041 ()
040-1751-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT IT
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125027 ()
040-1749-00

  • Electrocardiographic long-term ambulatory recording analyser
DR200 holter recorder w/ 7L patient cable
Northeast Monitoring, Inc.
DR200 7L
In Commercial Distribution

  • M581NEMK960 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 2.0 Centimeter
  • Weight: 70.9 Gram
NEMK96

  • Electrocardiographic long-term ambulatory recording analyser
DR200 holter recorder w/ 5L patient cable
Northeast Monitoring, Inc.
DR200 5L
In Commercial Distribution

  • M581NEMK950 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 2.0 Centimeter
  • Weight: 70.9 Gram
NEMK95

  • Electrocardiographic long-term ambulatory recording analyser
DR200 holter recorder w/ 2L patient cable
Northeast Monitoring, Inc.
DR200 2L
In Commercial Distribution

  • M581NEMK940 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 2.0 Centimeter
  • Weight: 70.9 Gram
NEMK94

  • Electrocardiographic long-term ambulatory recording analyser
LX Event Tool (TelePro)
Northeast Monitoring, Inc.
LX Event Tool
In Commercial Distribution

  • M581NEMK1950 ()
NEMK195

  • Electrocardiographic long-term ambulatory recording analyser
DR400 holter recorder with NEMEL002/003 patches
Northeast Monitoring, Inc.
DR400
In Commercial Distribution

  • M581NEMK1570 ()

  • Length: 6.7 Centimeter
  • Width: 3.8 Centimeter
  • Depth: 1.2 Centimeter
  • Weight: 35 Gram
NEMK157

  • Electrocardiographic long-term ambulatory recording analyser
Gateway NEMK156
Northeast Monitoring, Inc.
Gateway
In Commercial Distribution

  • M581NEMK1560 ()

  • Width: 3.8 Centimeter
  • Length: 6.7 Centimeter
  • Depth: 1.2 Centimeter
  • Weight: 35 Gram
NEMK156

  • Electrocardiographic long-term ambulatory recording analyser
No Description
Northeast Monitoring, Inc.
DR300 7L
In Commercial Distribution

  • M581NEMK1550 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 2.0 Centimeter
  • Weight: 70.9 Gram
NEMK155

  • Electrocardiographic long-term ambulatory recording analyser
DR300 holter recorder w/ 5L patient cable
Northeast Monitoring, Inc.
DR300 5L
In Commercial Distribution

  • M581NEMK1540 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 2.0 Centimeter
  • Weight: 70.9 Gram
NEMK154

  • Electrocardiographic long-term ambulatory recording analyser
DR181 holter recorder w/ 10L patient cable
Northeast Monitoring, Inc.
DR181 12L
In Commercial Distribution

  • M581NEMK1400 ()

  • Length: 12.5 Centimeter
  • Width: 7.0 Centimeter
  • Width: 2.5 Centimeter
  • Weight: 200 Gram


  • Electrocardiographic long-term ambulatory recording analyser
DR181 holter recorder w/ 7L patient cable
Northeast Monitoring, Inc.
DR181 7L
In Commercial Distribution

  • M581NEMK1390 ()

  • Length: 12.5 Centimeter
  • Width: 7.0 Centimeter
  • Width: 2.5 Centimeter
  • Weight: 200 Gram
NEMK139

  • Electrocardiographic long-term ambulatory recording analyser
DR200 holter recorder w/ 3L patient cable
Northeast Monitoring, Inc.
DR200 3L
In Commercial Distribution

  • M581NEMK1290 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 1.2 Centimeter
  • Weight: 70.9 Gram
NEMK129

  • Electrocardiographic long-term ambulatory recording analyser
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
CARDIOCALL VS20, PROGRAMMABLE
SPACELABS HEALTHCARE (WASHINGTON), INC
EVENTREC
Not in Commercial Distribution

  • 10841522106941 ()
CCVS20X4

  • Electrocardiographic long-term ambulatory recording analyser
CARDIOCALL VS20,ENGLISH PROGRAMMABLE
SPACELABS HEALTHCARE (WASHINGTON), INC
EVENTREC
Not in Commercial Distribution

  • 10841522106934 ()
CCVS20

  • Electrocardiographic long-term ambulatory recording analyser
CARDIOCALLST80X4 039/0249/1
SPACELABS HEALTHCARE (WASHINGTON), INC
EVENTREC
Not in Commercial Distribution

  • 10841522106903 ()
CCST80X4

  • Electrocardiographic long-term ambulatory recording analyser
CARDIOCALL ST80,ENGLISH ECG RECORDER
SPACELABS HEALTHCARE (WASHINGTON), INC
EVENTREC
Not in Commercial Distribution

  • 10841522106897 ()
CCST80

  • Electrocardiographic long-term ambulatory recording analyser
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
LIFESCREEN PRO ANALYSER, V1.X
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifescreen Pro
In Commercial Distribution

  • 10841522128837 ()
98800

  • Electrocardiographic long-term ambulatory recording analyser
INSTALLATION KIT, PATHFINDER SL 1.9.2
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522128820 ()
040-1763-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT DE
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
In Commercial Distribution

  • 10841522125737 ()
040-1756-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT NL
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125713 ()
040-1754-00

  • Electrocardiographic long-term ambulatory recording analyser
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