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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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Adult Intracardiac Sucker Tip - 8.8 mm diameter. Tips are grooved and slotted to allow for better flow and prevent clogging. For use with the Round Adult Handle 30 Degree Angle (1450-01), the Round Adult Handle 90 Degree Angle (1450-01-90) OR the Flat Adult Handle (1480-04)
PEMCO INC
1450-06
In Commercial Distribution

  • B1521450060 ()

  • Outer Diameter: 8.8 Millimeter
1450-06

  • Suction cannula, reusable
Adult Intracardiac Sucker Tip - 10.5 mm diameter. Tips are grooved and slotted to allow for better flow and prevent clogging. For use with the Round Adult Handle 30 Degree Angle (1450-01), the Round Adult Handle 90 Degree Angle (1450-01-90) OR the Flat Adult Handle (1480-04)
PEMCO INC
1450-05
In Commercial Distribution

  • B1521450050 ()

  • Outer Diameter: 10.5 Millimeter
1450-05

  • Suction cannula, reusable
The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings.
ELITECHGROUP INC.
Model 3400
In Commercial Distribution

  • 03661540304088 ()


  • Chloride coulometric titration analyser IVD, semi-automated
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Erythromycin 0.016 - 256μg/m are specialized strips impregnated with a predefined concentration gradient of Erythromycin for susceptibility testing of Staphylococcus aureus.
LIOFILCHEM SRL
Erythromycin 0.016 - 256μg/mL 1 strip
In Commercial Distribution

  • 28055182870282 ()
  • 08055182870288 ()
  • 18055182870285 ()
$92051-1

  • Erythromycin minimum inhibitory concentration (MIC) IVD
MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.
LIOFILCHEM SRL
PENICILLIN G P 0.002-32 µg/mL 10 Strip
In Commercial Distribution

  • 18055182872876 ()
  • 08055182872879 ()
  • 08055182872855 ()
$92103-10

  • Penicillin G minimum inhibitory concentration (MIC) IVD
MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.
LIOFILCHEM SRL
PENICILLIN G P 0.002-32 µg/mL 1 Strip
In Commercial Distribution

  • 28055182872866 ()
  • 08055182872862 ()
  • 18055182872869 ()
$92103-1

  • Penicillin G minimum inhibitory concentration (MIC) IVD
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Erythromycin 0.016 - 256μg/m are specialized strips impregnated with a predefined concentration gradient of Erythromycin for susceptibility testing of Staphylococcus aureus.
LIOFILCHEM SRL
Erythromycin 0.016 - 256μg/mL 10 strips
In Commercial Distribution

  • 18055182870292 ()
  • 08055182870295 ()
  • 08055182870271 ()
$92051-10

  • Erythromycin minimum inhibitory concentration (MIC) IVD
Ceftolozane 30μg Tazobactam 10μg (C/T40) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z9345
In Commercial Distribution

  • 00816576022045 ()
  • 00816576022021 ()
Z9345

  • Multiple antibacterial susceptibility profile kit IVD
Ceftolozane 30μg Tazobactam 10μg (C/T40) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z9341
In Commercial Distribution

  • 00816576022038 ()
  • 00816576022021 ()
Z9341

  • Multiple antibacterial susceptibility profile kit IVD
Ceftazidime 30μg Avibactam 20μg (CZA50) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z9355
In Commercial Distribution

  • 00816576022014 ()
  • 00816576021994 ()
Z9355

  • Multiple antibacterial susceptibility profile kit IVD
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