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 Class Implantable

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NOVA GLU/LAC SENSOR SOAKING SOLUTION
NOVA BIOMEDICAL CORPORATION
1
In Commercial Distribution

  • 00385480134095 ()
13409

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Cartridge, CG4+
ABBOTT POINT OF CARE INC.
03P85-51
In Commercial Distribution

  • 00054749005505 ()
  • 10054749005502 ()
03P85-51

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies v1.0
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480544228 ()
  • 00385480544221 ()
54422

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Wireless Carrying Case for Meter and Supplies
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480534397 ()
  • 00385480534390 ()
53439

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Docking Station
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480534021 ()
  • 00385480534024 ()
53402

  • Glucose monitoring system IVD, point-of-care
Statsensor Statstrip Docking Station 4 position
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480519967 ()
  • 00385480519960 ()
51996

  • Glucose monitoring system IVD, point-of-care
StatSensor StatStrip Docking Station for Wireless Carrying Case
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480486290 ()
  • 00385480486293 ()
48629

  • Glucose monitoring system IVD, point-of-care
StatSensor StatStrip Docking Station
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480422250 ()
  • 00385480422253 ()
42225

  • Glucose monitoring system IVD, point-of-care
StatStrip Docking Station Remanufactured 4 position 1.75
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480560372 ()
  • 00385480560375 ()
56037

  • Glucose monitoring system IVD, point-of-care
StatStrip Docking Station Remanufactured 2 position 1.75
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480560365 ()
  • 00385480560368 ()
56036

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480544198 ()
  • 00385480544191 ()
54419

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Docking Station
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480534014 ()
  • 00385480534017 ()
53401

  • Glucose monitoring system IVD, point-of-care
StatStrip StatSensor Docking Station
NOVA BIOMEDICAL CORPORATION
1.75
In Commercial Distribution

  • 10385480534007 ()
  • 00385480534000 ()
53400

  • Glucose monitoring system IVD, point-of-care
Statsensor Statstrip Docking Station 2 position
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480519950 ()
  • 00385480519953 ()
51995

  • Glucose monitoring system IVD, point-of-care
Statsensor Statstrip Docking Station
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480519943 ()
  • 00385480519946 ()
51994

  • Glucose monitoring system IVD, point-of-care
StatSensor StatStrip Docking Station Remanufactured
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480517567 ()
  • 00385480517560 ()
51756

  • Glucose monitoring system IVD, point-of-care
StatSensor StatStrip Wireless Carrying Case for Meter and Supplies
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480486306 ()
  • 00385480486309 ()
48630

  • Glucose monitoring system IVD, point-of-care
StatSensor Stat Strip Docking Station Non Network Capable
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480438060 ()
  • 00385480438063 ()
43806

  • Glucose monitoring system IVD, point-of-care
No Description
Epocal Inc
HR-1R04-00-00
In Commercial Distribution

  • 00809708116712 ()
HR-1R04-00-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1R09-JP-JP
In Commercial Distribution

  • 00809708075583 ()
HH-1R09-JP-JP

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1009-JP-JP
In Commercial Distribution

  • 00809708075576 ()
HH-1009-JP-JP

  • Metabolic profile clinical chemistry analyser IVD
EPOC BGEM CREA TEST CARD
Epocal Inc
CT-1006-00-00
In Commercial Distribution

  • 00809708072254 ()
CT-1006-00-00

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
No Description
Epocal Inc
HH-1R09-CA-00
In Commercial Distribution

  • 00809708069124 ()
HH-1R09-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1009-CA-00
In Commercial Distribution

  • 00809708069117 ()
HH-1009-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R03-CA-00
In Commercial Distribution

  • 00809708064068 ()
HH-0R03-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R05-CA-00
In Commercial Distribution

  • 00809708064051 ()
HH-0R05-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0005-CA-00
In Commercial Distribution

  • 00809708064044 ()
HH-0005-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0010-JP-JP
In Commercial Distribution

  • 00809708055899 ()
HH-0010-JP-JP

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1R09-00-00
In Commercial Distribution

  • 00809708053901 ()
HH-1R09-00-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1009-00-00
In Commercial Distribution

  • 00809708052898 ()
HH-1009-00-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0005-XU-00
In Commercial Distribution

  • 00809708049393 ()
HH-0005-XU-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0005-00-00
In Commercial Distribution

  • 00809708049379 ()
HH-0005-00-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-1009-CN-ZH
In Commercial Distribution

  • 00809708097219 ()
HH-1009-CN-ZH

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R05-XU-00
In Commercial Distribution

  • 00809708049409 ()
HH-0R05-XU-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R05-00-00
In Commercial Distribution

  • 00809708049386 ()
HH-0R05-00-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
CT-1004-00-00
In Commercial Distribution

  • 00809708047283 ()
CT-1004-00-00

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
No Description
Epocal Inc
HH-0R03-00-00
In Commercial Distribution

  • 00809708032340 ()
HH-0R03-00-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HR-1R02-00-00
In Commercial Distribution

  • 00809708032333 ()
HR-1R02-00-00

  • Metabolic profile clinical chemistry analyser IVD
EPOC READER
Epocal Inc
HR-1002-00-00
In Commercial Distribution

  • 00809708016685 ()
HR-1002-00-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0003-00-00
In Commercial Distribution

  • 00809708016678 ()
HH-0003-00-00

  • Metabolic profile clinical chemistry analyser IVD
Ready Sensor™ Chloride Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10376880
In Commercial Distribution

  • 00630414570488 ()
  • 00630414010212 ()
10376880

  • Chloride (Cl-) IVD, kit, ion-selective electrode (ISE)
Ready Sensor™ Sodium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10376878
In Commercial Distribution

  • 00630414570464 ()
  • 00630414010199 ()
10376878

  • Sodium (Na+) electrode IVD
RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1260 can determine pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate parameters
Siemens Healthcare Diagnostics Inc.
10321846
In Commercial Distribution

  • 00630414515564 ()
5062460

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1245 can determine pH, pCO2, pO2, tHb, nBili, FO2Hb, FCOHb, FMetHb, FHHb parameters
Siemens Healthcare Diagnostics Inc.
10321844
In Commercial Distribution

  • 00630414515557 ()
5061537

  • Blood gas/haemoximetry analyser IVD, point-of-care
Ready Sensor™ pO2 Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10321856
In Commercial Distribution

  • 00630414492650 ()
5065575

  • Blood oxygen electrode IVD
Reference Electrode Refill. An in vitro diagnostic device for use on the RAPIDLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10324388
In Commercial Distribution

  • 00630414492643 ()
6451843

  • Ion selective electrode (ISE) reference solution IVD, reagent
Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10324386
In Commercial Distribution

  • 00630414492636 ()
6449458

  • Ion selective electrode (ISE) reference solution IVD, reagent
RAPIDLab® 1200 Series CO-ox Sample Chamber for in vitro diagnostics use.
Siemens Healthcare Diagnostics Inc.
10324165
In Commercial Distribution

  • 00630414492629 ()
6324604

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDLab® 1200 Systems Wash Cartridge, for in vitro diagnostic use with RAPIDLab® 1200 series systems
Siemens Healthcare Diagnostics Inc.
10319817
In Commercial Distribution

  • 00630414492612 ()
3913056

  • Multiple blood gas analyte IVD, calibrator
Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10326708
In Commercial Distribution

  • 00630414132051 ()
673701000

  • Lactate electrode IVD
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