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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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FPPL Care One SPS +/-
Ahold U.S.A., Inc.
One Step Pregnancy Test
Not in Commercial Distribution

  • 00041520171269 ()
  • 10041520171266 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Care One Automatic Digital BP Monitor Jumbo Display-Arm, Wide Range Cuff
Ahold U.S.A., Inc.
67-554
In Commercial Distribution

  • 00041520105158 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Care One Pulse Oximeter
Ahold U.S.A., Inc.
67-50K
In Commercial Distribution

  • 00041520105134 ()


  • Pulse oximeter probe, reusable
Ecstasy Pouched Strip 100/box
AMERICAN BIO MEDICA CORPORATION
10-XTCS-000
In Commercial Distribution

  • 10694644800064 ()
  • 10694644850069 ()
10-XTCS-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
THC pouched strip 100/box
AMERICAN BIO MEDICA CORPORATION
10-THCS-000
In Commercial Distribution

  • 10694644800057 ()
  • 10694644850052 ()
10-THCS-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Cocaine pouched strips 100/box
AMERICAN BIO MEDICA CORPORATION
10-COCS-000
In Commercial Distribution

  • 10694644800040 ()
  • 10694644850045 ()
10-COCS-000

  • Cocaine/cocaine metabolite IVD, calibrator
Opi 2K pouched strips 100/box
AMERICAN BIO MEDICA CORPORATION
10-OPIS-001
In Commercial Distribution

  • 10694644800033 ()
  • 10694644850038 ()
10-OPIS-001

  • Opiate/opiate metabolite IVD, calibrator
Opi 300 pouched strip 100/box
AMERICAN BIO MEDICA CORPORATION
10-OPIS-000
In Commercial Distribution

  • 10694644800026 ()
  • 10694644850021 ()
10-OPIS-000

  • Opiate/opiate metabolite IVD, calibrator
Methamphetamine pouch str 100
AMERICAN BIO MEDICA CORPORATION
10-METS-000
In Commercial Distribution

  • 10694644800019 ()
  • 10694644850014 ()
10-METS-000

  • Amphetamine/methamphetamine group IVD, calibrator
Amp pouched strip 100/box
AMERICAN BIO MEDICA CORPORATION
10-AMPS-000
In Commercial Distribution

  • 10694644800002 ()
  • 10694644850007 ()
10-AMPS-000

  • Amphetamine-specific IVD, calibrator
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