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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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ICU Medical - 00840619046613

TriOx™ ScvO2 Central Venous Catheter, Basic Kit
ICU MEDICAL, INC.
50465-01
In Commercial Distribution

  • 10840619046610 ()
  • 00840619046613 ()
50465-01

  • Pulmonary artery balloon catheter, oximetric

ICU Medical - 00840619046590

TriOx™ SO2 Umbilical Artery Catheter U425, 4F, 25cm
ICU MEDICAL, INC.
50405-01
In Commercial Distribution

  • 10840619046597 ()
  • 00840619046590 ()
504050401

  • Pulmonary artery balloon catheter, oximetric

ICU Medical - 00840619045371

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

  • 10840619045378 ()
  • 00840619045371 ()
504040401

  • Pulmonary artery balloon catheter, oximetric

ICU Medical - 00840619030117

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

ICU Medical - 00840619030094

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

ICU Medical - 00840619030087

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

  • 10840619030084 ()
  • 00840619030087 ()
50472-01

  • Pulmonary artery balloon catheter, oximetric

ICU Medical - 00840619085957

Opticath Catheter P7110-EH, 7.5F, 110 cm, Heparin Coated
ICU MEDICAL, INC.
886-50324-07
In Commercial Distribution

  • 10840619085954 ()
  • 00840619085957 ()
886-50324-07

  • Pulmonary artery balloon catheter, oximetric

ICU Medical - 00840619079345

OptiQ, SvO2/CCO Catheter, 8F, 110 cm, J-Tip, Heparin Coated
ICU MEDICAL, INC.
886-52510-14
In Commercial Distribution

  • 10840619079342 ()
  • 00840619079345 ()
886-52510-14

  • Pulmonary artery balloon catheter, oximetric

Dario Blood Glucose Monitoring System - 00850065006000

The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
LABSTYLE INNOVATION LTD
1015-01
In Commercial Distribution

  • 00850065006000 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system

Diamatrix - 00813059015259

Bonfadini DALK Spatula with beveled tip, 1mm wide with horizontal groove on top, Angled/Vaulted 45 Degree at 8mm from bend to tip, Flat Handle, 123mm Overall Length, Stainless Steel .
Diamatrix
H668-S
In Commercial Distribution

  • 00813059015259 ()


  • Ocular hook/spatula/manipulator, reusable
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