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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CUSTOM PACK BB11P03R CITRS BB
MEDTRONIC, INC.
BB11P03R
In Commercial Distribution

  • 00763000496944 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11X80R3 BB PUMP
MEDTRONIC, INC.
BB11X80R3
In Commercial Distribution

  • 00763000763985 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11X80R2 BB PUMP
MEDTRONIC, INC.
BB11X80R2
In Commercial Distribution

  • 00763000715656 ()


  • Cardiopulmonary bypass system blood tubing set
Dermapal Digi BB 220V 50Hz
DAAVLIN DISTRIBUTING CO., THE
Dermapals
In Commercial Distribution

  • B2809935DPBDT50 ()


  • Ultraviolet phototherapy unit, professional
DIGITAL DERMAPAL BB 120V 60HZ
DAAVLIN DISTRIBUTING CO., THE
DIGITAL DERMAPAL
Not in Commercial Distribution

  • B280935DPBDT600 ()
935DPBDT60

  • Ultraviolet phototherapy unit, professional
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10429
In Commercial Distribution

  • 05055273217650 ()
CQ10429

  • Multiple cardiac marker IVD, control
This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10428
In Commercial Distribution

  • 05055273217346 ()
CQ10428

  • Multiple cardiac marker IVD, control
Monkey Heart 8 Well Slides, Pack of 12
MARDX DIAGNOSTICS, INC.
10-5408
In Commercial Distribution

  • 05391516747813 ()
10-5408

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Cardiac Positive Control, 0.5 mL
MARDX DIAGNOSTICS, INC.
10-5402
In Commercial Distribution

  • 05391516747806 ()
10-5402

  • Multiple cardiac marker IVD, control
Monkey Heart 4 Well Slides, 12 each/pack
MARDX DIAGNOSTICS, INC.
10-5404
In Commercial Distribution

  • 05391516747790 ()
10-5404

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
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