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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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TriOx™ SvO2 PA Catheter P7110-EP8-H, 8F, 110cm, Extra Port, Heparin Coated, LF
ICU MEDICAL, INC.
50328
In Commercial Distribution

  • 10840619059849 ()
  • 00840619059842 ()
50328-08

  • Pulmonary artery balloon catheter, oximetric
TriOx™ SvO2 PA Catheter P7110-EP8-H, 8F, 110cm, Extra Port, Heparin Coated
ICU MEDICAL, INC.
50328
In Commercial Distribution

  • 10840619059832 ()
  • 00840619059835 ()
50328-07

  • Pulmonary artery balloon catheter, oximetric
TriOx™ SvO2/CCO PA Catheter, 8F, 110cm, J-Tip, Heparin Coated
ICU MEDICAL, INC.
52510
In Commercial Distribution

  • 10840619059825 ()
  • 00840619059828 ()
52510-14

  • Pulmonary artery balloon catheter, oximetric
Intravesical Admin Kit for Oncology
ICU MEDICAL, INC.
CH3324
In Commercial Distribution

  • 10840619054240 ()
  • 00840619054243 ()


  • Pulmonary artery balloon catheter, oximetric
TriOx™ SO2 Umbilical Artery Catheter U425, 4F, 25cm
ICU MEDICAL, INC.
50405-01
In Commercial Distribution

  • 10840619046597 ()
  • 00840619046590 ()
504050401

  • Pulmonary artery balloon catheter, oximetric
TriOx™ ScvO2 Central Venous Oximetry Catheter, Heparin Coated, Expanded Kit
ICU MEDICAL, INC.
50456-01
In Commercial Distribution

  • 10840619030114 ()
  • 00840619030117 ()
50456-01

  • Pulmonary artery balloon catheter, oximetric
TriOx™ ScvO2 Central Venous Oximetry Catheter, Heparin Coated, Basic Kit
ICU MEDICAL, INC.
50458-01
In Commercial Distribution

  • 10840619030091 ()
  • 00840619030094 ()
50458-01

  • Pulmonary artery balloon catheter, oximetric
TriOx™ ScvO2 Central Venous Oximetry Catheter, Heparin Coated
ICU MEDICAL, INC.
50472
In Commercial Distribution

  • 10840619030084 ()
  • 00840619030087 ()
50472-01

  • Pulmonary artery balloon catheter, oximetric
Clave™ Connector IV Bag Access Device
ICU MEDICAL, INC.
011-CS-10
In Commercial Distribution

  • 10840619005952 ()
  • 00840619005955 ()
011-CS-10

  • Luer-formatted bag access spike
ACETABULAR CUP, PLASMA SPRAY 66
Conformis, Inc.
HCC032B06601
In Commercial Distribution

  • M572HCC032B066011 ()

  • Outer Diameter: 66 Millimeter
HCC032B066

  • Ceramic-on-polyethylene total hip prosthesis
  • Metal-on-polyethylene total hip prosthesis
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