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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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Specimen Cups With Leak Proof Screw on Lids - 3.5oz 50
Avaline Medical NJ Limited Liability Company
Sc3.5 x 50
In Commercial Distribution

  • 00850025452939 ()
  • 00810077213445 ()
Sc3.5 x 50

  • Urine specimen collection kit IVD
Specimen Cups With Leak Proof Screw on Lids - 4oz [Pack of 5] Non-Sterile Urine Sample Containers
Avaline Medical NJ Limited Liability Company
nssc x 5
In Commercial Distribution

  • 00850025452618 ()
  • 00810077212745 ()
nssc x 5

  • Urine specimen collection kit IVD
Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
Covidien LP
CB-CO-4 x 5
Not in Commercial Distribution

  • 20884521140209 ()
  • 10884521140202 ()
  • 30884521140206 ()

  • Width: 4 Inch
  • Length: 15 Feet
CB-CO-4 x 5

  • Wound compression dressing
Sterile Polyester Tipped Applicators
Puritan Medical Products
25-800 2PDBG
In Commercial Distribution

  • 50609576381299 ()
  • 00609576381294 ()
25-800 2PDBG

  • General-purpose absorbent tip applicator/swab, single-use
These CRP Controls Set are intended for use in CRP test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. C-reactive protein (CRP) is described in the literature as an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. CRP is one of the most sensitive indicators of inflammation.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
L1 x 3 x 3mL, L2 x 3 x 3mL
In Commercial Distribution

  • 00812137012159 ()
  • 00812137012425 ()
502-155

  • C-reactive protein (CRP) IVD, control
The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution

  • 00812137012067 ()
  • 00812137012319 ()
501-419

  • High density lipoprotein (HDL) cholesterol IVD, reagent
This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Throughout the circulatory life of the red cell, Hemoglobin A1c is formed continuously by the adduction of glucose to the N-terminal of the hemoglobin beta chain. This process, which is non-enzymatic, reflects the average exposure of hemoglobin to glucose over an extended period.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
L1 x 2 x 0.5mL, L2 x 2 x 0.5mL
In Commercial Distribution

  • 00812137012166 ()
  • 00812137012449 ()
502-156

  • Glycated haemoglobin (HbA1c) IVD, control
The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution

  • 00812137012074 ()
  • 00812137012340 ()
501-420

  • Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry
For the quantitative determination of magnesium in serum. For in vitro diagnostic use only. Magnesium in the body is found primarily in bone with some in soft tissue, blood cells, and serum. Decreased levels have been observed in cases of diabetes, alcoholism, diuretics, hyperthyroidism, hypothyroidism, malabsorption, hyperalimenation, myocardial infarction, congestive heart failure and liver cirrhosis. Increased serum magnesium levels have been found in renal failure, diabetic acidosis, Addison’s disease, and vitamin D intoxication.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 120mL, R2 x 2 x 120mL
In Commercial Distribution

  • 00812137012012 ()
  • 00812137012364 ()
501-414

  • Magnesium (Mg2+) IVD, reagent
29MM ASCENDRA+ DELIVERY SYSTEM
Edwards Lifesciences LLC
9355AS29
In Commercial Distribution

  • 00690103193732 ()

  • 29 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355AS29A

  • Cardiac valvuloplasty catheter
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