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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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anti-AMACR [13H4] / p63 [MX013] / CK5/6 [D5/16B4] PIN Antibody Cocktail, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8485-M100
In Commercial Distribution

  • 00615233008718 ()
8485-M100

  • p504s protein IVD, antibody
  • p63 tumour protein IVD, antibody
  • Cytokeratin IVD, antibody
100strips/ 1 bottle
DFI CO.,LTD
31I4
Not in Commercial Distribution

  • 08806141303060 ()


  • Urine pH IVD, kit, rapid colorimetric, clinical
FPPL Dollar General DPS +/-
DOLGENCORP, LLC
FPPL
Not in Commercial Distribution

  • 00430000702084 ()
  • 10430000702081 ()
  • 00633472000133 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
FPPL Dollar General SPS +/- 24 Pack
DOLGENCORP, LLC
FPPL
Not in Commercial Distribution

  • 00430000702091 ()
  • 10430000702098 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, USA
Respironics, Inc.
BiPAP Auto BiFlex, w/HT Humid System One 60 Series, US
In Commercial Distribution

  • 00606959006027 ()
DS760TS

  • Home BPAP unit
BiPAP Auto BiFlex with Heated Tube Humidifier System One 60 Series, AHP
Respironics, Inc.
BiPAP Auto BiFlex, w/HTD Humid, System One 60 Srs, AHP
In Commercial Distribution

  • 00606959005990 ()
AH760TS

  • Home BPAP unit
BiPAP Pro BiFlex, with Heated Tube Humidifier, System One 60 Series, USA
Respironics, Inc.
BiPAP Pro BiFlex, w/HT Humid System One 60 Series, US
In Commercial Distribution

  • 00606959005969 ()
DS660TS

  • Home BPAP unit
BiPAP Pro BiFlex, with Heated Tube Humidifier, System One 60 Series AHP
Respironics, Inc.
BiPAP Pro BiFlex, w/Htd Humid, Sys One 60 Srs, AHP
In Commercial Distribution

  • 00606959005938 ()
AH660TS

  • Home BPAP unit
BiPAP Pro BiFlex, with Heated Tube Humidifier, System One 60 Series, AHP
Respironics, Inc.
BiPAP Pro BiFlex with Humidifier, System One 60 Srs, AHP
In Commercial Distribution

  • 00606959005921 ()
AH660HS

  • Home BPAP unit
REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, USA
Respironics, Inc.
REMstar Pro C-Flex+, w/HT Humid System One 60 Series US
In Commercial Distribution

  • 00606959005846 ()
DS460TS

  • Home CPAP unit
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