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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. - 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

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

CMSViewer CD(FDA) - 06944904086422

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

  • 06944904086422 ()


  • Noninvasive device battery charger
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