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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

PathfinderSL; SENTINEL - 10841522103209

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

PATHFINDER SL, SENTINEL10 - 10841522103193

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

PathfinderSL - 10841522103087

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

ILR ECG Analyzer - 03770025266008

No Description
Implicity Inc.
V1.1.4
In Commercial Distribution

  • 03770025266008 ()
IM007

  • Cardiology information system application software

RHYTHMIA HDx™ - 08714729971306

EGM Out to Signal Station Cable (IBI™)
BOSTON SCIENTIFIC CORPORATION
M004RA61020
In Commercial Distribution

  • 08714729971306 ()
M004RA61020

  • Electrical-only medical device connection cable, reusable

RHYTHMIA HDx™ - 08714729971290

EGM Out to Signal Station Cable (Stockert™)
BOSTON SCIENTIFIC CORPORATION
M004RA60020
In Commercial Distribution

  • 08714729971290 ()
M004RA60020

  • Electrical-only medical device connection cable, reusable

RHYTHMIA HDx™ - 08714729965879

Signal Station
BOSTON SCIENTIFIC CORPORATION
M004RH1020R0
In Commercial Distribution

  • 08714729965879 ()


  • Transducer signal amplifier

RHYTHMIA HDx™ - 08714729965862

Signal Station
BOSTON SCIENTIFIC CORPORATION
M004RH1020H0
In Commercial Distribution

  • 08714729965862 ()


  • Transducer signal amplifier

RHYTHMIA HDx™ - 08714729960096

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBEVAL2END0
In Commercial Distribution

  • 08714729960096 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729952862

Signal Station Kit
BOSTON SCIENTIFIC CORPORATION
M004RH1000R0
In Commercial Distribution

  • 08714729952862 ()


  • Transducer signal amplifier

RHYTHMIA HDx™ - 08714729948407

Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40100
In Commercial Distribution

  • 08714729948407 ()
M004RH40100

  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729948384

Foot Switch
BOSTON SCIENTIFIC CORPORATION
M004RH15010
In Commercial Distribution

  • 08714729948384 ()
M004RH15010

  • Foot-switch, electrical

iLab™ Polaris Multi-Modality Guidance System - 08714729946137

Integrated System
BOSTON SCIENTIFIC CORPORATION
H74939322120I0
In Commercial Distribution

  • 08714729946137 ()


  • Cardiovascular ultrasound imaging system

iLab™ Polaris Multi-Modality Guidance System - 08714729946120

Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120CR0
In Commercial Distribution

  • 08714729946120 ()


  • Cardiovascular ultrasound imaging system

iLab™ Polaris Multi-Modality Guidance System - 08714729946113

Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120CD0
In Commercial Distribution

  • 08714729946113 ()


  • Cardiovascular ultrasound imaging system

iLab™ Polaris Multi-Modality Guidance System - 08714729946106

Mobile System
BOSTON SCIENTIFIC CORPORATION
H74939322120C0
In Commercial Distribution

  • 08714729946106 ()


  • Cardiovascular ultrasound imaging system

IBP Cable Kit - 08714729940425

Connecting Cable, Cable Adapter
BOSTON SCIENTIFIC CORPORATION
H7495553710
In Commercial Distribution

  • 08714729940425 ()


  • Cardiovascular ultrasound imaging system

FFR Link - 08714729939603

FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H749555100R0
In Commercial Distribution

  • 08714729939603 ()


  • Cardiovascular ultrasound imaging system

FFR Link - 08714729939597

FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H749555100H0
In Commercial Distribution

  • 08714729939597 ()


  • Cardiovascular ultrasound imaging system

RHYTHMIA HDx™ - 08714729938736

Localization Generator
BOSTON SCIENTIFIC CORPORATION
M004RH20010
In Commercial Distribution

  • 08714729938736 ()
M004RH20010

  • Electromagnetic surgical navigation device tracking system

RHYTHMIA HDx™ - 08714729938712

Signal Station
BOSTON SCIENTIFIC CORPORATION
M004RH10200
In Commercial Distribution

  • 08714729938712 ()


  • Transducer signal amplifier

RHYTHMIA HDx™ - 08714729938682

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2EN0
In Commercial Distribution

  • 08714729938682 ()


  • Cardiac mapping system

LABSYSTEM™ PRO - 08714729935926

PCIe DVI Image Capture Card
BOSTON SCIENTIFIC CORPORATION
M00420020350
In Commercial Distribution

  • 08714729935926 ()


  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729935919

Adapter Kit PCIe DVI Image Capture Card
BOSTON SCIENTIFIC CORPORATION
M00420020320
In Commercial Distribution

  • 08714729935919 ()


  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729935902

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034R0
Not in Commercial Distribution

  • 08714729935902 ()
M0042002034R0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729935896

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034H0
Not in Commercial Distribution

  • 08714729935896 ()
M0042002034H0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729935889

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002034D0
Not in Commercial Distribution

  • 08714729935889 ()
M0042002034D0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729935872

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M00420020340
Not in Commercial Distribution

  • 08714729935872 ()
M00420020340

  • General-purpose multi-parameter bedside monitor

Rhythmia™ Mapping System - 08714729907060

IntellaNav™ CB - Maestro™
BOSTON SCIENTIFIC CORPORATION
M004RA62500
In Commercial Distribution

  • 08714729907060 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729905899

ECG Out Box and Cable Kit 1 US
BOSTON SCIENTIFIC CORPORATION
M004RB5000US0
In Commercial Distribution

  • 08714729905899 ()


  • Cardiac mapping system

iLab Ultrasound Imaging System - 08714729902911

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240C271R0
In Commercial Distribution

  • 08714729902911 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729902904

Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240C2710
In Commercial Distribution

  • 08714729902904 ()


  • Cardiovascular ultrasound imaging system

iLab Ultrasound Imaging System - 08714729902867

Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB220C271R0
In Commercial Distribution

  • 08714729902867 ()


  • Cardiovascular ultrasound imaging system

GE Hemodynamic Cable Kit - 08714729897217

Connecting Cable
BOSTON SCIENTIFIC CORPORATION
H7495551310
In Commercial Distribution

  • 08714729897217 ()


  • Cardiovascular ultrasound imaging system

NA - 08714729895862

Motordrive Unit (MD5)
BOSTON SCIENTIFIC CORPORATION
H749I5033EUR0
In Commercial Distribution

  • 08714729895862 ()


  • Cardiovascular ultrasound imaging system

FFR Link - 08714729890010

FFR Signal Processing Module
BOSTON SCIENTIFIC CORPORATION
H7495551000
In Commercial Distribution

  • 08714729890010 ()


  • Cardiovascular ultrasound imaging system

MDU5 PLUS - 08714729887560

Motordrive Unit
BOSTON SCIENTIFIC CORPORATION
H749MDU5PLUSRR0
In Commercial Distribution

  • 08714729887560 ()


  • Cardiovascular ultrasound imaging system

LABSYSTEM™ PRO - 08714729886013

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002029R0
Not in Commercial Distribution

  • 08714729886013 ()
M0042002029R0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729886006

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002029H0
Not in Commercial Distribution

  • 08714729886006 ()
M0042002029H0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729885993

EP Recording System
BOSTON SCIENTIFIC CORPORATION
M0042002029D0
Not in Commercial Distribution

  • 08714729885993 ()
M0042002029D0

  • General-purpose multi-parameter bedside monitor
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