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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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PowerHeal 3-layer clear adhesive, 2.3 x 3.5
Vomaris Wound Care, Inc.
2.3" x 3.5"
In Commercial Distribution

  • 00810198031522 ()

  • Length: 2.3 Inch
  • Width: 3.5 Inch
PFK-2335

  • Bioelectric wound dressing
Procellera Single Layer Rx, 5" x 5"
Vomaris Wound Care, Inc.
5" x 5"
In Commercial Distribution

  • 00894318002579 ()
  • 00810198030808 ()
  • 00810198030815 ()
VSR-0505

  • Bioelectric wound dressing
Procellera Single Layer OTC, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198030389 ()
VSC-0404

  • Bioelectric wound dressing
Procellera Single Layer OTC, 2"x2"
Vomaris Wound Care, Inc.
2"x 2"
In Commercial Distribution

  • 00810198030372 ()
VSC-0202

  • Bioelectric wound dressing
Procellera Single Layer Rx 12" x 12"
Vomaris Wound Care, Inc.
12" x 12"
In Commercial Distribution

  • 00810198030358 ()
  • 00810198030310 ()
  • 00810198030365 ()
VSR-1212

  • Portable pneumatic high-frequency ventilator
Procellera Single Layer Rx 8" x 8"
Vomaris Wound Care, Inc.
8" X 8"
In Commercial Distribution

  • 00810198030327 ()
  • 00810198030303 ()
  • 00810198030334 ()
  • 00810198030341 ()
VSR-0808

  • Bioelectric wound dressing
Procellera Single Layer Rx, 4" x 8"
Vomaris Wound Care, Inc.
4" x 8"
In Commercial Distribution

  • 00810198030013 ()
  • 10810198030010 ()
VSR-0408

  • Bioelectric wound dressing
For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
2 x 2mL
In Commercial Distribution

  • 00812137012173 ()
  • 00812137012463 ()
502-157

  • Total iron binding capacity (TIBC) IVD, calibrator
The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP Reagents. For in vitro diagnostic use only. The calibrators in this kit contain known quantities of human C-reactive protein. These reagents are to be used as calibrators with the manufacturer’s CRP Reagents.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
5 x 2mL
In Commercial Distribution

  • 00812137012142 ()
  • 00812137012432 ()
502-154

  • C-reactive protein (CRP) IVD, calibrator
The Chemistry Control Level I is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
10 x 5mL
In Commercial Distribution

  • 00812137012128 ()
  • 00812137012388 ()
502-152

  • Multiple-type clinical chemistry analyte profile IVD, control
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