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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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Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741231186

Site~Rite 9 Ultrasound Software v.1.2.0
Bard Access Systems, Inc.
SR9v1.2.0
In Commercial Distribution

  • 00801741231186 ()
SR9v1.2.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

Site Rite 8 Ultrasound System - 00801741219405

Site Rite 8 Ultrasound System Application Software
Bard Access Systems, Inc.
SR8v2.4.0
In Commercial Distribution

  • 00801741219405 ()
SR8v2.4.0

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741161094

Site~Rite 8 Ultrasound System Host Software
Bard Access Systems, Inc.
SR8 USv2.1.0
In Commercial Distribution

  • 00801741161094 ()
SR8 USv2.1.0

  • General-purpose ultrasound imaging system

Lumax™ TS Pro Advanced - 60888937013391

Lumax™ TS Pro Advanced • Software Kit
Coopersurgical, Inc.
23486
In Commercial Distribution

  • 60888937013391 ()


  • Urodynamic measurement system

LABSYSTEM™ PRO - 08714729975700

LABSYSTEM™ PRO EP Review Workstation Software
BOSTON SCIENTIFIC CORPORATION
M00420020620
In Commercial Distribution

  • 08714729975700 ()
M00420020620

  • Cardiopulmonary physiological parameter analysis software

Welch Allyn, Inc. - 00817655021058

Resting ECG connectivity gateway software v.5.0.0
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655021058 ()
11027-024-50

  • Electrocardiograph, professional, multichannel

Cytomics FC500 - 15099590572822

Cytomics FC 500 MPL with MXP Software
Beckman Coulter, Inc.
UPS (MPL)
In Commercial Distribution

  • 15099590572822 ()
626554

  • Flow cytometry analyser IVD, semi-automated

Navios EX - 15099590683276

NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution

  • 15099590683276 ()
B91240

  • Laboratory instrument/analyser application software IVD

ECG - 15099169413334

BT12 ECG AHA WITH SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution

  • 05099169413337 ()
  • 15099169413334 ()


  • Electrocardiograph, professional, multichannel

ECG - 15099169413303

BT-12 ECG IEC with SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution

  • 05099169413306 ()
  • 15099169413303 ()


  • Electrocardiograph, professional, multichannel
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