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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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Remanufactured Stat Profile pHOx Ultra CO-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA CO OX
In Commercial Distribution

  • 10385480420171 ()
  • 00385480420174 ()
42017

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile pHOx Ultra Co-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA CO OX
In Commercial Distribution

  • 10385480420133 ()
  • 00385480420136 ()
42013

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
The GoodLife AC-300 Professional Blood Glucose Monitoring System.(No NFC)
HMD BIOMEDICAL INC.
AC11-NFC
Not in Commercial Distribution

  • 04711200721850 ()
  • 04711200722154 ()
3K-01-16003G

  • Home-use/point-of-care blood glucose/blood pressure monitoring system
Infant Flow LP Bonnet & Straps, 36-38 cm
VYAIRE MEDICAL, INC.
777028
In Commercial Distribution

  • 50190752184495 ()
  • 10190752184497 ()
777028

  • Respiratory oxygen therapy system
Infant Flow LP Bonnent & Straps, 34-36 cm
VYAIRE MEDICAL, INC.
777026
In Commercial Distribution

  • 50190752184488 ()
  • 10190752184480 ()
777026

  • Respiratory oxygen therapy system
Infant Flow LP Bonnet & Straps, 32-34 cm
VYAIRE MEDICAL, INC.
777024
In Commercial Distribution

  • 50190752184471 ()
  • 10190752184473 ()
777024

  • Respiratory oxygen therapy system
Infant Flow LP Bonnet & Straps, 30-32 cm
VYAIRE MEDICAL, INC.
777022
In Commercial Distribution

  • 50190752184464 ()
  • 10190752184466 ()
777022

  • Respiratory oxygen therapy system
Infant Flow LP Bonnent & Straps, 28-30 cm
VYAIRE MEDICAL, INC.
777020
In Commercial Distribution

  • 50190752184457 ()
  • 10190752184459 ()
777020

  • Respiratory oxygen therapy system
4 Handpiece
STRYKER CORPORATION
5290601100
Not in Commercial Distribution

  • 04546540427885 ()
5290-601-100

  • Line-powered surgical power tool system motor
GoodLife AC Blood Glucose Test Strips
HMD BIOMEDICAL INC.
AC11-Foil
Not in Commercial Distribution

  • 00389154000075 ()
  • 00389154000556 ()
3K-01-16003C

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