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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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Sentinel - 10841522103094

SENTINEL 10 WORKSTATION (X1) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103094 ()
040-1709-00

  • Cardiology information system application software

Sentinel - 10841522103452

Cardiology Information Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103452 ()
10.0.1

  • Cardiac stress exercise monitoring system

PathfinderSL - 10841522103131

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103131 ()
040-1713-00

  • Cardiology information system application software

SENTINEL - 10841522103124

SENTINEL 10 WORKSTATION (X10) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103124 ()
040-1712-00

  • Cardiology information system application software

Pathfinder - 10841522125645

PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200
Not in Commercial Distribution

  • 10841522125645 ()
040-1726-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software

Pathfinder - 10841522124563

PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200
Not in Commercial Distribution

  • 10841522124563 ()
040-1726-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser

Sentinel - 10841522123269

SENTINEL 10.0.1 STANDALONE WORKSTAT LICENCE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123269 ()
040-1702-00

  • Cardiology information system application software

Sentinel - 10841522123252

SENTINEL 10.0.1 OFFLINE/NETWORK WORKSTAT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123252 ()
040-1705-00

  • Cardiology information system application software

Sentinel - 10841522123245

SENTINEL 10.0.1 NETWORK WORKSTATION LICENSE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123245 ()
040-1703-00

  • Cardiology information system application software

Sentinel - 10841522123238

SENTINEL 10.0.1 ADD. NETWORK WORKSTAT LICENSE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123238 ()
040-1704-00

  • Cardiology information system application software

SENTINEL - 10841522123221

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123221 ()
040-1713-00

  • Cardiology information system application software

TechCare Trauma - 03770024774047

No Description
MILVUE
V1.1.x
In Commercial Distribution

  • 03770024774047 ()


  • Radiological PACS software

Rayvolve - 03770018071084

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over).
AZMED
4
In Commercial Distribution

  • 03770018071084 ()


  • X-ray image interpretive software

Rayvolve - 03770018071077

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over). (Variant : Full Cloud)
AZMED
4
In Commercial Distribution

  • 03770018071077 ()


  • X-ray image interpretive software

Rayvolve - 03770018071060

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over). (Variant : VM + Cloud)
AZMED
4
In Commercial Distribution

  • 03770018071060 ()


  • X-ray image interpretive software

Rayvolve - 03770018071022

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Cloud/VM)
AZMED
2
In Commercial Distribution

  • 03770018071022 ()


  • X-ray image interpretive software

Rayvolve - 03770018071015

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Full Cloud)
AZMED
2
In Commercial Distribution

  • 03770018071015 ()


  • X-ray image interpretive software

Rayvolve - 03770018071008

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : On premise)
AZMED
2
In Commercial Distribution

  • 03770018071008 ()


  • X-ray image interpretive software

BoneView - 03770020839085

No Description
GLEAMER
1.1.X
In Commercial Distribution

  • 03770020839085 ()


  • Radiological PACS software

BoneView - 03770020839009

No Description
GLEAMER
1.X-US
In Commercial Distribution

  • 03770020839009 ()


  • Radiological PACS software

SphygmoCor - 19351315000017

Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others]. CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL: • CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)] • CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
ATCOR MEDICAL PTY LTD
CVMS
In Commercial Distribution

  • 19351315000017 ()
  • 19351315000024 ()


  • Patient monitoring system module, multifunction

Endowrist SP - 00886874122228

CAMERA, 0°
INTUITIVE SURGICAL, INC.
430077
In Commercial Distribution

  • 00886874122228 ()

  • Outer Diameter: 6 Millimeter


  • Rigid optical laparoscope

NA - 00721902046940

SFTWR 9767 HEAD PRGMG RF TLMY SYS A/B
MEDTRONIC, INC.
9767
In Commercial Distribution

  • 00721902046940 ()


  • Cardiac pulse generator programmer

Medtronic CareLink® Programmer - 00721902824692

PRGM 2090AA4 PORTABLECRM
MEDTRONIC, INC.
2090AA4
Not in Commercial Distribution

  • 00721902824692 ()


  • Cardiac pulse generator programmer

NA - 00721902710353

CABLE R2067L RFHEAD 14FT REFURB
MEDTRONIC, INC.
R2067L
In Commercial Distribution

  • 00721902710353 ()

  • Length: 14.0 Feet


  • Cardiac pulse generator programmer

NA - 00721902710346

CABLE R2067 RF HEAD 9FT WRLDW REFURB
MEDTRONIC, INC.
R2067
In Commercial Distribution

  • 00721902710346 ()

  • Length: 9.0 Feet


  • Cardiac pulse generator programmer

NA - 00721902546655

ECG PLUG 148743-1 US
MEDTRONIC, INC.
148743-1
In Commercial Distribution

  • 00721902546655 ()


  • Cardiac pulse generator programmer

SJM™ - 05414734501668

Telemetry Wand
ST. JUDE MEDICAL, INC.
3630
In Commercial Distribution

  • 05414734501668 ()
3630

  • Cardiac pulse generator programmer

CareLink Encore™ - 00643169763548

PRGM 29901A ENCORE US EIFU
MEDTRONIC, INC.
29901A
In Commercial Distribution

  • 00643169763548 ()


  • Cardiac pulse generator programmer

WiSE CRT System - 00859244007296

Programmer
EBR Systems, Inc.
5100
In Commercial Distribution

  • 00859244007296 ()


  • Cardiac pulse generator programmer
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