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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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Blood Culture Collection Kit, Baptist Medical Center South Only
AERO-MED, LLC
CA15850
Not in Commercial Distribution

  • 50885380164130 ()
  • 10885380164132 ()
CA15850

  • Phlebotomy kit
Personal Use Kit OC-Auto, for KPS South bay (HBRCTY)
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-KPS SB
In Commercial Distribution

  • 00816917020402 ()


  • Faecal occult blood IVD, reagent
MTS L/H KIT 1 -SOUTH AUSTIN HOSP PG
MEDLINE INDUSTRIES, INC.
60183292
In Commercial Distribution

  • 20193489050025 ()
  • 10193489050028 ()
60183292

  • Angiography kit
Precision Flow Oxygen Assist Module, Nellcor UKIT South Africa
VAPOTHERM, INC.
OAM-NEL-UKIT-ZA
In Commercial Distribution

  • 00841737104315 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Oxygen Assist Module, Masimo UKIT South Africa
VAPOTHERM, INC.
OAM-MAS-UKIT-ZA
In Commercial Distribution

  • 00841737104308 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
Oxidant Reagent (CC445)
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC445
In Commercial Distribution

  • 00817302024678 ()

  • Total Volume: 500 Milliliter
  • Kit contains 2 R1 bottles
CC445

  • Drug/toxicology adulteration IVD, kit, spectrophotometry
Aldolase
CAROLINA LIQUID CHEMISTRIES CORPORATION
CALD-015
In Commercial Distribution

  • 00817302024654 ()

  • Total Volume: 15 Milliliter
  • Kit contains 10 R1 bottles
CALD-015

  • Aldolase IVD, reagent
MULTI-DRUG CONTROL (UDT-CNTL)
CAROLINA LIQUID CHEMISTRIES CORPORATION
UDT-CNTL
In Commercial Distribution

  • 00817302024630 ()

  • Total Volume: 18 Milliliter
  • Kit contains 1 R1 bottle, 1 R2 bottle, 1 R3 bottle, and 1 R4 bottle
UDT-CNTL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Phosphorus (PHOS) Reagent
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST218
In Commercial Distribution

  • 00817302024579 ()

  • Kit contains 4 R1 bottles
  • Total Volume: 56 Milliliter
ST218

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Triglycerides (TRIG) Reagent
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST213
In Commercial Distribution

  • 00817302024562 ()

  • Kit contains 4 R1 bottles and 4 R2 bottles
  • Total Volume: 9 Milliliter
  • Total Volume: 59 Milliliter
ST213

  • Triglyceride IVD, kit, spectrophotometry
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