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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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HUDSON RCI - 14026704658777

In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm I.D.
TELEFLEX INCORPORATED
IPN029718
In Commercial Distribution

  • 24026704658774 ()
  • 14026704658777 ()
  • 04026704595501 ()
1743

  • Cardiac sizing catheter

HUDSON RCI - 14026704717702

In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm I.D.
TELEFLEX INCORPORATED
IPN916675
In Commercial Distribution

  • 24026704717709 ()
  • 14026704717702 ()
RHO743U

  • Cardiac sizing catheter

ACCURUN® - 00850041090030

No Description
Lgc Clinical Diagnostics, Inc.
2000-0102
In Commercial Distribution

  • 00850041090030 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

ACCURUN® - 00850041090023

No Description
Lgc Clinical Diagnostics, Inc.
2015-0240
In Commercial Distribution

  • 00850041090023 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

ACCURUN® - 00850041090016

No Description
Lgc Clinical Diagnostics, Inc.
2010-0023
In Commercial Distribution

  • 00850041090016 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

ACCURUN® - 00850041090009

No Description
Lgc Clinical Diagnostics, Inc.
2000-0101
In Commercial Distribution

  • 00850041090009 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

ACON SARS-CoV-2 IgG/IgM Rapid Test - 00682607200979

Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution

  • 20682607200973 ()
  • 00682607200979 ()
  • 00682607002269 ()
200979

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Health o meter Professional - 00854896003641

Mechanical Diaper Scale
Pelstar, LLC
YG500R
In Commercial Distribution

  • 00854896003641 ()


  • Laboratory scale, mechanical

Rapid Response - 00722066000304

Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution

  • 00722066000304 ()
  • 00722066004258 ()
HPY-13C15

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Trinity Biotech - 05391516747714

EIA Color Developer, 13.0 mL
MARDX DIAGNOSTICS, INC.
40-1006
In Commercial Distribution

  • 05391516747714 ()
40-1006

  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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