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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 - 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

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

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

PTS-X™ - 04046964512186

PTSX406 PTSX BALLOON 40MM X 6CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613752
Not in Commercial Distribution

  • 04046964512186 ()
613752

  • Cardiac sizing catheter

PTS-X™ - 04046964512179

PTSX405 PTSX BALLOON 40MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613751
In Commercial Distribution

  • 04046964512179 ()
613751

  • Cardiac sizing catheter

PTS-X™ - 04046964512155

PTSX403 PTSX BALLOON 40MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613749
In Commercial Distribution

  • 04046964512155 ()
613749

  • Cardiac sizing catheter

PTS-X™ - 04046964512131

PTSX355 PTSX BALLOON 35MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613747
Not in Commercial Distribution

  • 04046964512131 ()
613747

  • Cardiac sizing catheter

PTS-X™ - 04046964512124

PTSX354 PTSX BALLOON 35MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613746
In Commercial Distribution

  • 04046964512124 ()
613746

  • Cardiac sizing catheter

PTS-X™ - 04046964512117

PTSX353 PTSX BALLOON 35MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613745
Not in Commercial Distribution

  • 04046964512117 ()
613745

  • Cardiac sizing catheter
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