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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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Nova Max - 00385480434362

Nova Max Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480434369 ()
  • 00385480434362 ()
  • 20385480434366 ()
43436

  • Multiple clinical chemistry analyte monitoring system IVD, home-use

Nova Max - 00385480434355

Nova Max Plus Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480434352 ()
  • 00385480434355 ()
  • 20385480434359 ()
43435

  • Multiple clinical chemistry analyte monitoring system IVD, home-use

StatStrip - 00385480434041

StatStrip Xpress Glucose Meter and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
Xpress
In Commercial Distribution

  • 10385480434048 ()
  • 00385480434041 ()
43404

  • Glucose monitoring system IVD, point-of-care

StatStrip - 00385480422246

StatStrip Glucose Meter With Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480422243 ()
  • 00385480422246 ()
42224

  • Glucose monitoring system IVD, point-of-care

Nova Max - 00385480458245

Nova Max Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480458242 ()
  • 00385480458245 ()
  • 20385480458249 ()
45824

  • Multiple clinical chemistry analyte monitoring system IVD, home-use

StatSensor - 00385480440523

StatSensor Creatinine Meter with Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480440520 ()
  • 00385480440523 ()
44052

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

StatStrip - 00385480437738

StatStrip GLU Meter and Quick Reference Guide Remanufactured
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480437735 ()
  • 00385480437738 ()
43773

  • Glucose monitoring system IVD, point-of-care

STAT PROFILE - 00385480420181

Remanufactured Stat Profile pHOx Ultra Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA
In Commercial Distribution

  • 10385480420188 ()
  • 00385480420181 ()
42018

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

STAT PROFILE - 00385480420174

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 - 00385480420143

Stat Profile pHOx Ultra ABG Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA
In Commercial Distribution

  • 10385480420140 ()
  • 00385480420143 ()
42014

  • Blood gas analyser IVD, point-of-care
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