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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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No Description
Avante
60144TIBP
In Commercial Distribution

  • 00815871020954 ()


  • Pulse oximeter, line-powered
  • General-purpose multi-parameter bedside monitor
No Description
Avante
60144NP
In Commercial Distribution

  • 00815871020947 ()


  • Pulse oximeter, line-powered
  • General-purpose multi-parameter bedside monitor
No Description
Avante
60144IBP
In Commercial Distribution

  • 00815871020930 ()


  • Pulse oximeter, line-powered
  • General-purpose multi-parameter bedside monitor
No Description
Avante
60144CO2S
In Commercial Distribution

  • 00815871020923 ()


  • Pulse oximeter, line-powered
  • General-purpose multi-parameter bedside monitor
No Description
Avante
60144CO2
In Commercial Distribution

  • 00815871020916 ()


  • Pulse oximeter, line-powered
  • General-purpose multi-parameter bedside monitor
No Description
Avante
60144
In Commercial Distribution

  • 00815871020909 ()


  • Pulse oximeter, line-powered
  • General-purpose multi-parameter bedside monitor
No Description
Avante
60146TESP
In Commercial Distribution

  • 00815871021418 ()


  • Pulse oximeter, line-powered
  • General-purpose multi-parameter bedside monitor
The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer. Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0030
In Commercial Distribution

  • EABA40000301 ()
  • EABA40000300 ()
400-0030

  • Glucose/ketone/lipid profile IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Glucose IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
The VX220 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: keratometer, corneal topographer, tonometer,and pachymeter and retro illumination
LUNEAU TECHNOLOGY OPERATIONS
VX220
In Commercial Distribution

  • 03664188002200 ()


  • Ophthalmic tonometer, battery-operated
  • Optical pachymeter
Kit Contains: C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX C8XX2, GELPORT 120MM CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2813
In Commercial Distribution

  • 30607915135189 ()


  • Laparoscopic multi-instrument access port, single-use
  • Laparoscopic access cannula, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Ligation clip, metallic
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