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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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The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
3059
In Commercial Distribution

  • 00050428526859 ()
  • 10050428526856 ()
3059

  • Glycated haemoglobin (HbA1c) monitoring system IVD, home-use
Voltage: AC 110-120V 60Hz, Max pressure: 95 psi (preset), Air flow at 0 psi: ~37 l/min, Air flow at 50 psi: ~17 l/min
Dynarex Corporation
33952
In Commercial Distribution

  • 00840117324008 ()
  • 00840117327498 ()


  • Medical device air compressor
Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-2
In Commercial Distribution

  • 30858512007045 ()
  • 10858512007041 ()

  • Total Volume: 30 Milliliter
303-2

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-1
In Commercial Distribution

  • 10858512007034 ()
  • 30858512007038 ()

  • Total Volume: 30 Milliliter
303-1

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-2
In Commercial Distribution

  • 30858512007014 ()
  • 10858512007010 ()

  • Total Volume: 20 Milliliter
301-2

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-1
In Commercial Distribution

  • 30858512007007 ()
  • 10858512007003 ()

  • Total Volume: 20 Milliliter
301-1

  • Multiple urine analyte IVD, control
Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
1
Not in Commercial Distribution

  • 05714188502151 ()


  • Haematological concentrate system preparation kit, platelet concentration
Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
2
In Commercial Distribution

  • 05714188502106 ()


  • Haematological concentrate system preparation kit, platelet concentration
Large Mayo Stand Cover ,62X27,Level 4,Yellow Bias at top
Lac-Mac Limited
075XX
In Commercial Distribution

  • 00627755250636 ()

  • Height: 27 Inch
  • Width: 62 Inch
075XX

  • Patient surgical drape, reusable
30 M Corrugated Tube (22 mm,cuffed at 0.15 cm,transparent)
FOREMOUNT ENTERPRISE CO., LTD.
152102
In Commercial Distribution

  • 04719871894002 ()


  • Straight/elbow breathing circuit connector, single-use
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