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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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Pressure Injectable Arrowg+ard Blue Plus(R) Two-Lumen CVC Kit
TELEFLEX INCORPORATED
IPN029650
In Commercial Distribution

  • 20801902143840 ()
  • 10801902143843 ()
ASK-47702-PPHP1

  • Central venous catheterization kit, short-term
Arterial Line Kit
TELEFLEX INCORPORATED
IPN037227
In Commercial Distribution

  • 40801902119306 ()
  • 10801902119305 ()
ASK-04510-UTM1

  • Peripheral artery cannula
INSTI Test Controls HIV-1
Biolytical Laboratories Inc
80-1071
Not in Commercial Distribution

  • 06865978010710 ()
80-1071

  • HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical
INSTI HIV-1/HIV-2 Test Controls
Biolytical Laboratories Inc
80-1037
Not in Commercial Distribution

  • 06865978010376 ()
80-1037

  • HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical
Loading Units, 30±2mm Long, 2.5±0.2mm height, white
Ezisurg Medical Co., Ltd.
L30W
In Commercial Distribution

  • 66925776123554 ()
  • 06925776123552 ()
  • 76925776123551 ()
L30W

  • Endoscopic manual linear cutting stapler, single-use
CoolFlow SM.03.DTX Heat Transfer Fluid 1.5L
SPECTRUM MEDICAL LIMITED
SM.03.DTX
In Commercial Distribution

  • 05060434423757 ()
51-000089-00

  • Cardiopulmonary bypass system heating/cooling unit
LiquiCV EZ Enzyme Linearity Control
PHOENIX DIAGNOSTICS, INC.
PH5009
In Commercial Distribution

  • 00852676007070 ()
  • 10852676007077 ()

  • Total Volume: 5 Milliliter
PH5009

  • Multiple clinical chemistry enzyme IVD, control
The PTH Control Level 3 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyroid Hormone in human serum and plasma. The PTH Control Level 3 is assayed with target values and is suitable for use on many immunoassay analysers. The PTH Control Level 3 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
PTH10610
In Commercial Distribution

  • 05055273219838 ()
PTH10610

  • Parathyroid hormone (PTH) IVD, control
The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyroid Hormone in human serum and plasma. The PTH Control Level 2 is assayed with target values and is suitable for use on many immunoassay analysers. The PTH Control Level 2 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
PTH10609
In Commercial Distribution

  • 05055273219821 ()
PTH10609

  • Parathyroid hormone (PTH) IVD, control
The PTH Control Level 1 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyroid Hormone in human serum and plasma. The PTH Control Level 1 is assayed with target values and is suitable for use on many immunoassay analysers. The PTH Control Level 1 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
PTH10608
In Commercial Distribution

  • 05055273219814 ()
PTH10608

  • Parathyroid hormone (PTH) IVD, control
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