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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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X EP System LiveView Dynamic Display Software License
ST. JUDE MEDICAL, INC.
ENSITE-LV-01
In Commercial Distribution

  • 05415067037718 ()
ENSITE-LV-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-OT-01
In Commercial Distribution

  • 05415067037695 ()
ENSITE-D-OT-01

  • Cardiac mapping system application software
Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Quarterly
LIDCO LIMITED
Li11076Q
In Commercial Distribution

  • 05060110523054 ()
Li11076Q

  • General-purpose multi-parameter bedside monitor
Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Monthly
LIDCO LIMITED
Li11076M
In Commercial Distribution

  • 05060110523047 ()
Li11076M

  • General-purpose multi-parameter bedside monitor
Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Annual
LIDCO LIMITED
Li11076A
In Commercial Distribution

  • 05060110523023 ()
Li11076A

  • General-purpose multi-parameter bedside monitor
OnPoint Surgical Cart (with pre-installed software) - 2 headsets
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682485 ()
NK0210301

  • Orthopaedic stereotactic surgery system
OnPoint Surgical Cart (with pre-installed software) - 3 headsets
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682386 ()
NK0210301

  • Orthopaedic stereotactic surgery system
OnPoint Surgical Cart (with pre-installed software) - 1 headset
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682010 ()
NK0210101

  • Orthopaedic stereotactic surgery system
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.4.1
In Commercial Distribution

  • 00850049633253 ()
8.4.1

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.4.0
In Commercial Distribution

  • 00850049633246 ()
8.4.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.3.0
In Commercial Distribution

  • 00850049633239 ()
8.3.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.2.0
In Commercial Distribution

  • 00850049633161 ()
8.2.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.1.1
In Commercial Distribution

  • 00850049633130 ()
8.1.1

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.1.0
In Commercial Distribution

  • 00850049633123 ()
8.1.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.0.1
In Commercial Distribution

  • 00850049633109 ()
8.0.1

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.0.0
In Commercial Distribution

  • 00850049633055 ()
8.0.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.5
In Commercial Distribution

  • 00850049633048 ()
7.1.5

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.2
In Commercial Distribution

  • 00850049633031 ()
7.1.2

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.1
In Commercial Distribution

  • 00850049633024 ()
7.1.1

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
6.0 SP9 Patch 2
In Commercial Distribution

  • 00850049633017 ()
6.0 SP9 Patch 2

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.4
In Commercial Distribution

  • 00850049633000 ()
7.1.4

  • Medical equipment clinical data interfacing software
LABSYSTEM™ PRO EP Review Workstation Software, V2.7
BOSTON SCIENTIFIC CORPORATION
M00420020300
In Commercial Distribution

  • 08714729884002 ()


  • Cardiopulmonary physiological parameter analysis software
BD Pyxis MedBank Tower (MedPass Software v1.X)
CAREFUSION 303, INC.
SW-MP-V1
In Commercial Distribution

  • 10885403513817 ()


  • Anaesthesia cabinet
BD Pyxis Anesthesia Station 4000 (Software v6.X)
CAREFUSION 303, INC.
SW-PAS-4000-V6
In Commercial Distribution

  • 10885403513787 ()


  • Anaesthesia cabinet
BD Pyxis Anesthesia Station ES (Software v2.X)
CAREFUSION 303, INC.
SW-PAS-ES-V2
In Commercial Distribution

  • 10885403513770 ()


  • Anaesthesia cabinet
Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit
BioPlex 2200 System Operation Manual , Software Version 4.3
BIO-RAD LABORATORIES, INC.
SW Version 4.3
In Commercial Distribution

  • 03610520540633 ()

  • 1 EA
12000958

  • Fluorescent immunoassay analyser IVD, laboratory
BioPlex 2200 System Operation Manual , Software Version 4.2
BIO-RAD LABORATORIES, INC.
SW Version 4.2
In Commercial Distribution

  • 03610520505915 ()

  • 1 EA
6600813-4.2.1

  • Fluorescent immunoassay analyser IVD, laboratory
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.1
In Commercial Distribution

  • B9875X10 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.0
Not in Commercial Distribution

  • B9875X00 ()


  • Accelerator system quality assurance device
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