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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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Welch Allyn, Inc. - 00732094309478

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU, no display; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094309478 ()
HSCRIBE-6AB-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264081

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264081 ()
HSCRIBE-6AC-BXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264043

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264043 ()
HSCRIBE-6AC-DXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

MicroScan - 15099590703271

CD, Labpro V4.42 Panel Update-07 LabPro V4.42 Panel Update-07 Kit (US, OUS) LabPro V4.42 System Kit wPanel Update-07 (US,OUS)
Beckman Coulter, Inc.
V4.42
In Commercial Distribution

  • 15099590703110 ()
  • 15099590703271 ()
  • 15099590703127 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

Welch Allyn, Inc. - 00732094285444

Surveyor Central Repeater Node - English language and CD manual; 220V power; 0; Color LCD 24 in. monitor with high resolution
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094285444 ()
SCREP-AAB-XXBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262421

Surveyor Central Review Station - English language and CD manual; 220V power; Software kit; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262421 ()
SCREV-AAB-BXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262391

Surveyor Central Review Station - Italian language and CD manual; 220V power; Software kit; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262391 ()
SCREV-AEB-BXXXX

  • Centralized patient monitor

MAESTRO 8.0 CD - 09008737380625

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38062
In Commercial Distribution

  • 09008737380625 ()


  • Audiometric/hearing device software

SFG Sperm CD - 10850068289520

No Description
SPECTRUM FERTILITY GROUP INC.
S-D-SS3
In Commercial Distribution

  • 00850068289523 ()
  • 10850068289520 ()


  • Assisted reproduction procedure dish

SFG Sperm CD - 10850068289513

No Description
SPECTRUM FERTILITY GROUP INC.
S-D-SS2
In Commercial Distribution

  • 00850068289516 ()
  • 10850068289513 ()


  • Assisted reproduction procedure dish

SFG Sperm CD - 10850068289506

No Description
SPECTRUM FERTILITY GROUP INC.
S-D-SS1
In Commercial Distribution

  • 00850068289509 ()
  • 10850068289506 ()


  • Assisted reproduction procedure dish

PAP-8E Software CD - G0561071530

No Description
Bio/Data Corporation
107153
In Commercial Distribution

  • G0561071530 ()
107053

  • Platelet aggregation analyser IVD

LTA Check CD - G0561071490

No Description
Bio/Data Corporation
107149
In Commercial Distribution

  • G0561071490 ()
107149

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

POWERCHO-2 CD, 100L - 00840075402763

No Description
Lonza Walkersville, Inc.
08-911D
In Commercial Distribution

  • 00840075402763 ()
08-911D

  • Ex vivo cell culture medium

CMSViewer CD(FDA) - 06944904086422

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-034054-00
In Commercial Distribution

  • 06944904086422 ()


  • Noninvasive device battery charger

Noxturnal PSG CD - 15694311111368

No Description
Nox Medical ehf.
NOX-NOXTPSG_CD
In Commercial Distribution

  • 15694311111368 ()
539012

  • Sleep disorder interpretive software, professional-only

Welch Allyn, Inc. - 00732094259711

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259711 ()
XSCRIBE-6CC-CXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259513

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259513 ()
XSCRIBE-6CC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259483

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259483 ()
XSCRIBE-6CC-XXBXX

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094259056

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259056 ()
XSCRIBE-6XC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259049

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; No lead set; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259049 ()
XSCRIBE-6XC-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259360

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259360 ()
XSCRIBE-6DC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094323191

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094323191 ()
HSCRIBE-6AD-ZXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094318166

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094318166 ()
XSCRIBE-6XC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094264050

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264050 ()
HSCRIBE-6AC-DXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264036

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264036 ()
HSCRIBE-6AC-DXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Alpine BioMed - 05704736016810

"Keypoint Focus Module Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701
Not in Commercial Distribution

  • 05704736016810 ()


  • Electromyograph

GIOTTO IMAGE 3DL - 08033837190035

MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
MAW
In Commercial Distribution

  • 08033837190035 ()
  • 18033837190032 ()

  • Height: 1920 Millimeter
  • Depth: 470 Millimeter
  • Width: 1175 Millimeter
6006-15GM3

  • Radiology DICOM image processing application software

Summit Doppler - 00888937011357

Vantage ABI System Contents: Two 10 cm cuffs, two 12cm cuffs, four color-coded hoses, reporting software CD and USB memory stick.
Coopersurgical, Inc.
VANABI
In Commercial Distribution

  • 00888937011357 ()


  • Noninvasive vascular ultrasound system

Welch Allyn, Inc. - 00732094259599

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi- clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259599 ()
XSCRIBE-6CC-DXAXX

  • Cardiopulmonary stress exercise monitoring system computer
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