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 Class Implantable

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M-Tech Compatible LNCS (2319, 2328) Infant SpO2 Disposable Sensor
APK Technology Co.,Ltd.
MAS-2319-NC
In Commercial Distribution

  • 06946725540886 ()


  • Tissue saturation oximeter sensor, reprocessed
Nonin Compatible Infant finger soft , DB9(7pin) Reusable SpO2 Sensor
APK Technology Co.,Ltd.
A1414-SI103PU
In Commercial Distribution

  • 06946725539507 ()


  • Pulse Co-oximeter probe, reusable
Nellcor Compatible Reusable SpO2 Sensor, Pediatric Finger Clip
APK Technology Co.,Ltd.
A1418-SP103MV
In Commercial Distribution

  • 06946725538715 ()


  • Pulse Co-oximeter probe, reusable
Nonin Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1414-SA103PV
In Commercial Distribution

  • 06946725538036 ()


  • Pulse Co-oximeter probe, reusable
Nonin Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1414-SA103PU
In Commercial Distribution

  • 06946725538029 ()


  • Pulse Co-oximeter probe, reusable
Masimo Compatible, Adult Finger Clip, 1.0M
APK Technology Co.,Ltd.
S403-490
In Commercial Distribution

  • 06946725530283 ()


  • Pulse Co-oximeter probe, reusable
10XX2 PLUS BUP, OXY AND SVT pack in Bulk
AMERICAN BIO MEDICA CORPORATION
10-10SPX2AB-339
In Commercial Distribution

  • 10694644200291 ()
  • 10694644250296 ()
10-10SPX2AB-339

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 Rap Tox Cup w/PCP opi 2 SVT
AMERICAN BIO MEDICA CORPORATION
10-5PX2A-200
In Commercial Distribution

  • 10694644200031 ()
  • 10694644250036 ()
10-5PX2A-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Incup with THC/COC/OPI300/METH/BAR/MDMA/SVT
AMERICAN BIO MEDICA CORPORATION
10-6SPCA-308
In Commercial Distribution

  • 10694644400714 ()
  • 10694644450719 ()
10-6SPCA-308

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10X w/BUP/OXY NO PCP,PPX Op3 +SVT
AMERICAN BIO MEDICA CORPORATION
10-10BPXTA-030
In Commercial Distribution

  • 10694644100423 ()
  • 10694644150428 ()
10-10BPXTA-030

  • Buprenorphine IVD, calibrator
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