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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The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. 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 may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0033
In Commercial Distribution

  • EABA40000331 ()
  • EABA40000330 ()
400-0033

  • Urea IVD, reagent
  • Creatinine IVD, reagent
MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the quantitative evaluation of biliary system structures acquired from magnetic resonance (MR) images from a single time-point (a patient visit). A Perspectum-trained operator loads previously acquired magnetic resonance cholangiopancreatography (MRCP) data as input into the MRCP+ v2 device. A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts. The MRCP+ v2 report is intended to facilitate reporting by a radiologist for subsequent interpretation and to aid diagnosis by a physician as part of a panel of testing, including conventional radiological tools.
PERSPECTUM LTD
2.0.0
In Commercial Distribution

  • B554MRCP2000 ()


  • Radiology DICOM image processing application software
The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. 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 may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0006
In Commercial Distribution

  • EABA40000061 ()
  • EABA40000060 ()
400-0006

  • Gamma-glutamyltransferase (GGT) IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Glucose IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. 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 may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0029
In Commercial Distribution

  • EABA40000291 ()
  • EABA40000290 ()
400-0029

  • Total aspartate aminotransferase (AST) IVD, reagent
  • Glucose IVD, reagent
  • Total bilirubin IVD, reagent
  • Total protein IVD, reagent
  • Uric acid IVD, reagent
  • Creatinine IVD, reagent
  • Urea IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Total alkaline phosphatase (ALP) IVD, reagent
  • Total amylase IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Gamma-glutamyltransferase (GGT) IVD, reagent
  • Albumin IVD, reagent
The CQ-29CN / D-11 TDP infrared therapy lamp contains a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in heating coil in the TDP lamp head, it begins to emit FIR (far infrared) waves which, along with the ionized minerals, easily penetrates deep into the body to be absorbed. A digital control panel with a back-lit LCD screen is located on the stand. Get precise controls over different aspects of treatment. Set treatment duration with the built-in timer by pressing the Timing button—adjustable from 30-60 minutes in 5 minute increments. Power level is also adjustable by pressing Adjustment button to set power from 50-100% in 10% increments. The LCD display is large and clear giving you all the information you need at a glance. The CQ-29CN lamp is a free standing floor lamp with a 24" diameter wheeled base for convenient transport. With the telescoping main post and articulating neck, the emission head can be positioned as low as 21" to as high as 61" from the floor with the post fully extended. Tilt and swivel head allow multiple angles of treatment. Quick and easy assembly.
A & A MEDICAL SUPPLIES INC.
CQ-29CN
In Commercial Distribution

  • B465CQ29CN0 ()

  • Weight: 25 Pound
  • Width: 24 Inch
  • Adjustable Min/Max Height: 33.5"/62" above floor
D-11

  • Musculoskeletal infrared phototherapy unit, non-wearable
The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition the power cord, foot switch, and the door plug are connected to the base unit. The touch-screen serves as the main control panel. The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered. The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.
GME German Medical Engineering GmbH
1070
In Commercial Distribution

  • B12510700 ()
1070

  • Multi-modality skin surface treatment system
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