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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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Xhibit - 10841522107160

Central Station
SPACELABS HEALTHCARE (WASHINGTON), INC
96102
Not in Commercial Distribution

  • 10841522107160 ()
N/A

  • Centralized patient monitor

Spacelabs Healthcare - 10841522104985

KIT,START-UP,3-L ECG IEC,NIBP,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104985 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522104954

KIT,START-UP,5-L ECG IEC,NIBP,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104954 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522104947

KIT,START UP KIT UPGRADE,SKIN TEMP SENSOR
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104947 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522104930

KIT,START UP KIT UPGRADE,5-L ECG AAMI
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104930 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

UltraviewSL - 10841522102981

KIT, DM3 UPDATE, V1.8
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102981 ()
V1.8

  • Multiple vital physiological parameter monitoring system, clinical

UltraviewSL - 10841522102974

KIT, DM3 UPDATE, V1.7
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102974 ()
V1.7

  • Multiple vital physiological parameter monitoring system, clinical

qube - 10841522100574

COMPACT MONITOR, 91390, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube
In Commercial Distribution

  • 10841522100574 ()
R-91390

  • Multiple vital physiological parameter monitoring system, clinical

qube - 10841522100550

COMPACT MONITOR,91390
SPACELABS HEALTHCARE (WASHINGTON), INC
91390
Not in Commercial Distribution

  • 10841522100550 ()
91390

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522100536

DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522100536 ()
011-0241-01

  • Centralized patient monitor

Xhibit - 10841522100345

XHIBIT CENTRAL STATION,96102
SPACELABS HEALTHCARE (WASHINGTON), INC
96102
Not in Commercial Distribution

  • 10841522100345 ()
96102

  • Centralized patient monitor

qube mini - 10841522100239

QUBE MINI TRANSPORT MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
Not in Commercial Distribution

  • 10841522100239 ()
91389

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522100222

Remote Display Controller
SPACELABS HEALTHCARE (WASHINGTON), INC
91388
In Commercial Distribution

  • 10841522100222 ()
N/A

  • Centralized patient monitor

Playbook - 00840194493871

Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system

Rhythmia™ Mapping System - 08714729842118

Rhythmia Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004RH40000
In Commercial Distribution

  • 08714729842118 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729842033

ECG Box Out - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RH14000
In Commercial Distribution

  • 08714729842033 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729842026

Breakout Box MAP Out
BOSTON SCIENTIFIC CORPORATION
M004RH13000
In Commercial Distribution

  • 08714729842026 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729842019

Breakout Box B Out
BOSTON SCIENTIFIC CORPORATION
M004RH12500
In Commercial Distribution

  • 08714729842019 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729842002

Breakout Box B In
BOSTON SCIENTIFIC CORPORATION
M004RH12000
In Commercial Distribution

  • 08714729842002 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841999

Breakout Box A Out
BOSTON SCIENTIFIC CORPORATION
M004RH11500
In Commercial Distribution

  • 08714729841999 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841982

Breakout Box A In
BOSTON SCIENTIFIC CORPORATION
M004RH11000
In Commercial Distribution

  • 08714729841982 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841838

Conditioning Box
BOSTON SCIENTIFIC CORPORATION
M004RACONDITION0
In Commercial Distribution

  • 08714729841838 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841760

Connection Box - Maestro™
BOSTON SCIENTIFIC CORPORATION
M004RA62000
In Commercial Distribution

  • 08714729841760 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841753

Connection Box - IBI™
BOSTON SCIENTIFIC CORPORATION
M004RA61000
In Commercial Distribution

  • 08714729841753 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841746

Connection Box - Stockert™
BOSTON SCIENTIFIC CORPORATION
M004RA60000
In Commercial Distribution

  • 08714729841746 ()


  • Cardiac mapping system

Odyssey - M58800100701020

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Stereotaxis, Inc.
Quad HD
In Commercial Distribution

  • M58800100701020 ()
001-007010-2

  • Medical image management system

RHYTHMIA HDx™ - 08714729994077

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729986003

Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729985983

Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system

Playbook - 00840194471954

Playbook Assembly
ORTHOPEDIATRICS CORP.
01-4200-0001
Not in Commercial Distribution

  • 00840194471954 ()
01-4200-0001

  • Medical image management system
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