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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™ ScvO2 Central Venous Oximetry Catheter, Heparin Coated
ICU MEDICAL, INC.
50472
In Commercial Distribution

  • 10840619030084 ()
  • 00840619030087 ()
50472-01

  • Pulmonary artery balloon catheter, oximetric
Clave™ Conn, IV Bag Access Device, BCV
ICU MEDICAL, INC.
011-CS-15
In Commercial Distribution

  • 10840619006027 ()
  • 00840619006020 ()
011-CS-15

  • Luer-formatted bag access spike
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
Bag Spike, Vented, MicroClave™ Clear
ICU MEDICAL, INC.
MCH-14
In Commercial Distribution

  • 10840619078178 ()
  • 00840619078171 ()
MCH-14

  • Luer-formatted bag access spike
Intravesical Admin Kit for Oncology
ICU MEDICAL, INC.
CH3324
In Commercial Distribution

  • 10840619054240 ()
  • 00840619054243 ()


  • Pulmonary artery balloon catheter, oximetric
TriOx™ ScvO2 Central Venous Oximetry Catheter, Expanded Kit
ICU MEDICAL, INC.
50467-01
In Commercial Distribution

  • 10840619046627 ()
  • 00840619046620 ()
504670401

  • Pulmonary artery balloon catheter, oximetric
TriOx™ ScvO2 Central Venous Catheter, Basic Kit
ICU MEDICAL, INC.
50465-01
In Commercial Distribution

  • 10840619046610 ()
  • 00840619046613 ()
50465-01

  • 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™ SO2 Umbilical Artery Catheter U440, 4F, 40cm
ICU MEDICAL, INC.
50404-01
In Commercial Distribution

  • 10840619045378 ()
  • 00840619045371 ()
504040401

  • Pulmonary artery balloon catheter, oximetric
ACETABULAR CUP, PLASMA SPRAY 60
Conformis, Inc.
HCC032B06001
In Commercial Distribution

  • M572HCC032B060011 ()

  • Outer Diameter: 60 Millimeter
HCC032B060

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