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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No Description
APK Technology Co.,Ltd.
A0816-SP105PV
In Commercial Distribution

  • 06946725520444 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0816-SA105PU
In Commercial Distribution

  • 06946725520437 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0816-SA105PV
In Commercial Distribution

  • 06946725520420 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SW203PW
In Commercial Distribution

  • 06946725520109 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SP203PU
In Commercial Distribution

  • 06946725520093 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SP203PV
In Commercial Distribution

  • 06946725520086 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SA203PU
In Commercial Distribution

  • 06946725520079 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SA203PV
In Commercial Distribution

  • 06946725520062 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SW101PU
In Commercial Distribution

  • 06946725520048 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SP101PU
In Commercial Distribution

  • 06946725520031 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SP101PV
In Commercial Distribution

  • 06946725520024 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SA101PU
In Commercial Distribution

  • 06946725520017 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A0424-SA101PV
In Commercial Distribution

  • 06946725520000 ()


  • Tissue saturation oximeter sensor, reprocessed
No Description
APK Technology Co.,Ltd.
A1411-SN01
In Commercial Distribution

  • 06946725514245 ()


  • Pulse oximeter probe, single-use
No Description
APK Technology Co.,Ltd.
A1411-SI01
In Commercial Distribution

  • 06946725514238 ()


  • Pulse oximeter probe, single-use
No Description
APK Technology Co.,Ltd.
A1411-SP01
In Commercial Distribution

  • 06946725514221 ()


  • Pulse oximeter probe, single-use
No Description
APK Technology Co.,Ltd.
A1411-SA01
In Commercial Distribution

  • 06946725514214 ()


  • Pulse oximeter probe, single-use
No Description
APK Technology Co.,Ltd.
A0004D03
In Commercial Distribution

  • 06946725527153 ()


  • Electrocardiographic lead set, single-use
7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MET1000, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW17702B
In Commercial Distribution

  • 30817405023326 ()
  • 00817405023325 ()
  • 10817405023322 ()
ABTDUAW17702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR, NI, OX, pH, S.G.)
Instant Technologies, Inc.
ABTDUAW15701A
In Commercial Distribution

  • 30817405023296 ()
  • 00817405023295 ()
  • 10817405023292 ()
ABTDUAW15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW17701A
In Commercial Distribution

  • 30817405023265 ()
  • 00817405023264 ()
  • 10817405023261 ()
ABTDUAW17701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/OPI2000/PCP25/THC50/(OX/pH/SG)
NEXSCREEN, LLC
ND-60505N-3A
In Commercial Distribution

  • 00858984006248 ()
ND-60505N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MET500/OPI2000/THC50/(OX/pH/SG)
NEXSCREEN, LLC
ND-60500N-3A
In Commercial Distribution

  • 00858984006224 ()
ND-60500N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/(CR/SG/pH)
ADVIN BIOTECH, INC.
ABCupE-12-02
In Commercial Distribution

  • B115ABCUPE12021 ()
  • B115ABCUPE12020 ()
ABCupE-12-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MET500/OPI300/THC50/(CR/SG/pH)
ADVIN BIOTECH, INC.
ABCupE-05-02
In Commercial Distribution

  • B115ABCUPE05021 ()
  • B115ABCUPE05020 ()
ABCupE-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(CR/OX/pH)
ADVIN BIOTECH, INC.
ABCupD-12-01
In Commercial Distribution

  • B115ABCUPD12011 ()
  • B115ABCUPD12010 ()
ABCupD-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(CR/OX/Ph)
ADVIN BIOTECH, INC.
ABCupD-10-16
In Commercial Distribution

  • B115ABCUPD10161 ()
  • B115ABCUPD10160 ()
ABCupD-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MET500/OPI300/THC50/(CR/OX/Ph)
ADVIN BIOTECH, INC.
ABCupD-05-02
In Commercial Distribution

  • B115ABCUPD05021 ()
  • B115ABCUPD05020 ()
ABCupD-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/Ox/SG/pH/Cr/Ni/Gl
ADVIN BIOTECH, INC.
ABCupC-12-71
In Commercial Distribution

  • B115ABCUPC12710 ()
  • B115ABCUPC12711 ()
ABCupC-12-71

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50/Ox/SG/pH/Cr/Ni/Gl
ADVIN BIOTECH, INC.
ABCupC-12-44
In Commercial Distribution

  • B115ABCUPC12440 ()
  • B115ABCUPC12441 ()
ABCupC-12-44

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BZO300/COC150/MET500/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCupC-07-43
In Commercial Distribution

  • B115ABCUPC07430 ()
  • B115ABCUPC07431 ()
ABCupC-07-43

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI300/OXY100/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCupC-07-03
In Commercial Distribution

  • B115ABCUPC07031 ()
  • B115ABCUPC07030 ()
ABCupC-07-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(OX/pH/SG)
ADVIN BIOTECH, INC.
ABCupA-11-39
In Commercial Distribution

  • B115ABCUPA11390 ()
  • B115ABCUPA11391 ()
ABCupA-11-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/OPI2000/PCP25/THC50/(OX/pH/SG)
ADVIN BIOTECH, INC.
ABCupA-05-09
In Commercial Distribution

  • B115ABCUPA05091 ()
  • B115ABCUPA05090 ()
ABCupA-05-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/(CR/SG/pH)
ADVIN BIOTECH, INC.
ABCardE-12-02
In Commercial Distribution

  • B115ABCARDE12021 ()
  • B115ABCARDE12020 ()
ABCardE-12-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MET500/OPI300/THC50/(CR/SG/pH)
ADVIN BIOTECH, INC.
ABCardE-05-02
In Commercial Distribution

  • B115ABCARDE05021 ()
  • B115ABCARDE05020 ()
ABCardE-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50
ADVIN BIOTECH, INC.
ABCardD-12-01
In Commercial Distribution

  • B115ABCARDD12011 ()
  • B115ABCARDD12010 ()
ABCardD-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(CR/OX/pH)
ADVIN BIOTECH, INC.
ABCardD-10-16
In Commercial Distribution

  • B115ABCARDD10161 ()
  • B115ABCARDD10160 ()
ABCardD-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MET500/OPI300/THC50/(CR/OX/pH)
ADVIN BIOTECH, INC.
ABCardD-05-02
In Commercial Distribution

  • B115ABCARDD05021 ()
  • B115ABCARDD05020 ()
ABCardD-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/Ox/SG/pH/Cr/Ni/Gl
ADVIN BIOTECH, INC.
ABCardC-12-71
In Commercial Distribution

  • B115ABCARDC12710 ()
  • B115ABCARDC12711 ()
ABCardC-12-71

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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