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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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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

AMICUS Separator Legacy Software - 00810020441208

Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.51.0
In Commercial Distribution

  • 00810020441208 ()


  • Apheresis system

AMICUS Separator Legacy Software - 00810020440591

Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.13.0
In Commercial Distribution

  • 00810020440591 ()


  • Apheresis system

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

ViroSeq - 00884999039278

ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor
ABBOTT MOLECULAR INC.
4J94-23
In Commercial Distribution

  • 00884999039278 ()
4J94-23

  • Laboratory instrument/analyser application software IVD

Earlens ELF USB - 00850013007042

Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software

NA - M65810624240

Software, TomoApps, Version 5.1.3 Operating Software for TomoTherapy systems (including TomoH, TomoHD, TomoHDA) and Onrad Treatment System.
ACCURAY INCORPORATED
1062424
In Commercial Distribution

  • M65810624240 ()
NA

  • Linear accelerator system

VITEK®2 - 03573026619060

VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
BIOMERIEUX , INC.
9.01.1
In Commercial Distribution

  • 03573026619060 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
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