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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For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2170
In Commercial Distribution

  • 04086000100168 ()
  • 14086000100165 ()
X6C2170

  • Blood transfusion set, non-exchange
For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2339
In Commercial Distribution

  • 04086000100151 ()
  • 14086000100158 ()
X6R2339

  • Therapeutic plasma/red blood cell exchange tubing set
For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2172
In Commercial Distribution

  • 04052682031724 ()
  • 14052682031721 ()
X6C2172

  • Blood transfer set
For Administration of Blood and Blood Components During a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) Therapeutic Apheresis Procedure. For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2170
In Commercial Distribution

  • 04086000100168 ()
  • 04052682031717 ()
  • 14052682031714 ()
X6C2170

  • Blood transfusion set, non-exchange
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services
Forward Science Technologies LLC
BioStom 10ct
In Commercial Distribution

  • 00370275850502 ()


  • General oral wound dressing, non-animal-derived
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services.
Forward Science Technologies LLC
BioStom 25ct
In Commercial Distribution

  • 00370275850250 ()


  • General oral wound dressing, non-animal-derived
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services
Forward Science Technologies LLC
BioStom 1ct
In Commercial Distribution

  • 00370275850106 ()


  • General oral wound dressing, non-animal-derived
PCP (Phencyclidine)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-414
In Commercial Distribution

  • 00817302021653 ()

  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 60 Milliliter
  • Total Volume: 23 Milliliter
AU-414

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
PCP (Phencyclidine) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST314
In Commercial Distribution

  • 00817302021646 ()

  • Total Volume: 13 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 33 Milliliter
ST314

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
PCP (Phencyclidine) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST414
In Commercial Distribution

  • 00817302021639 ()

  • Total Volume: 63 Milliliter
  • Total Volume: 26 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
ST414

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
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