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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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CB Series Analysis & Reporting Software - 3 CH ECG
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020146 ()
A10-0032

  • Electrocardiographic long-term ambulatory recording analyser application software
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
LABSYSTEM™ PRO EP Review Workstation Software, V2.7
BOSTON SCIENTIFIC CORPORATION
M00420020300
In Commercial Distribution

  • 08714729884002 ()


  • Cardiopulmonary physiological parameter analysis software
VIDAS PC V4.9 W10 Software version for clinic
BIOMERIEUX SA
4.9
In Commercial Distribution

  • 03573026619527 ()


  • Fluorescent immunoassay analyser IVD, laboratory
Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit
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
ALPHA MULTISTORE ACQUISITION BOX HD INCLUSIVE SOFTWARE "PERSONAL"
Gimmi GmbH
S.2046.60 HD
In Commercial Distribution

  • 04049047653516 ()
S.2046.60 HD

  • Endoscopic video imaging system
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