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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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Liver (IgG) Marblot Strip Test System, Western Blot System for the Detection of IgG Antibody to Liver Antigens, 20 Tests
MARDX DIAGNOSTICS, INC.
41-1020G
In Commercial Distribution

  • 05391516748728 ()
41-1020G

  • Protein electrophoresis IVD, kit, electrophoresis
Androstenedione-ELISA
Diasource Immunoassays S.A. SA
KAPD3265
In Commercial Distribution

  • 05400569000865 ()


  • Androstenedione IVD, kit, enzyme immunoassay (EIA)
Lithium replacement battery for Philips(TM) Heartstream ForeRunner(TM) AED (BT1)
Amco International Manufacturing & Design, Inc.
5L318
In Commercial Distribution

  • 00853258006061 ()
5L318

  • Primary battery
Lithium replacement battery for Philips(TM) Heartstart(TM) FRx Onsite & Home(TM) AED.
Amco International Manufacturing & Design, Inc.
AM5070
In Commercial Distribution

  • 00853258006054 ()
AM5070

  • Primary battery
Lithium replacement battery for Philips(TM) HeartStart(TM) FR2 and FR2+
Amco International Manufacturing & Design, Inc.
6L785
In Commercial Distribution

  • 00853258006047 ()
6L785

  • Primary battery
Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, shipped after April 12, 2004, with 4 year full replacement guarantee. Color yellow.
Amco International Manufacturing & Design, Inc.
AM9146-2
In Commercial Distribution

  • 00853258006030 ()
AM9146-2

  • Primary battery
Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) AED G3 9300A,, 9300E shipped after April 12, 2004, with 4 year full replacement guarantee. Color white.
Amco International Manufacturing & Design, Inc.
AM9146-1
In Commercial Distribution

  • 00853258006023 ()
AM9146-1

  • Primary battery
Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) 9200RD, 9210RD, and Survivalink Firstsave(TM) 9100, 9110, 9200, 9210, 9200D, and 9210D
Amco International Manufacturing & Design, Inc.
AM9141
In Commercial Distribution

  • 00853258006016 ()
AM9141

  • Primary battery
Lithium replacement battery for Physio-Control LifePak 500(TM) AED
Amco International Manufacturing & Design, Inc.
5L500
In Commercial Distribution

  • 00853258006009 ()
5L500

  • Primary battery
Angel Processing Set Single Unit Kit or Tray with 016339 EU Processing Set Label
NUO THERAPEUTICS INC
976000601
In Commercial Distribution

  • 00852714003026 ()


  • Blood washing/centrifugation bag
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