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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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Perfetta Face Mask - 08938504806052

3 ply - Disposable High Filtration Face Mask Non- sterile, single use Color green 50 masks pack in one box
PHU BAO GROUP COMPANY LIMITED
Moderate Green
In Commercial Distribution

  • 89385048060528 ()
  • 08938504806052 ()


  • Surgical/medical face mask, single-use

Rapid Response - 10722066005337

Rapid Response FSH Menopause Test Cassette (Urine) - 25 tests/ kit for the qualitative detection of Follicle-stimulating hormone in urine.
BTNX Inc
FSH-1C25
In Commercial Distribution

  • 00722066005330 ()
  • 10722066005337 ()


  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Pointe Scientific, Inc. CK - 00811727014696

CK Reagent, for the quantitative determination of creatine kinase activity in serum. Size: 1 x 1L, 1 x 200ml
POINTE SCIENTIFIC, INC.
HC722-1200
In Commercial Distribution

  • 00811727014696 ()
HC722-1200

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

ASIA MED - 04251282509378

asia-med Kinesiology Tape - Royal Blue: made of cotton fabric with a medical grade acrylic adhesive applied in a wave pattern. Flexibility in longitudinal direction: approx. 60% (1:1,6)|Size: length 5 m, width 5 cm|Color: Royal Blue|Sales unit: 1 roll
asia-med GmbH
TAPE ROYAL BLUE, 5M X 5CM
In Commercial Distribution

  • 04251282509378 ()

  • Width: 5 Centimeter
  • Length: 5 Meter
A012162

  • Hypoallergenic skin adhesive tape

ASIA MED - 04251282509361

asia-med Kinesiology Tape - Dark Blue: made of cotton fabric with a medical grade acrylic adhesive applied in a wave pattern. Flexibility in longitudinal direction: approx. 60% (1:1,6)|Size: length 5 m, width 5 cm|Color: Dark Blue|Sales unit: 1 roll
asia-med GmbH
TAPE DARK BLUE, 5M X 5CM
In Commercial Distribution

  • 04251282509361 ()

  • Width: 5 Centimeter
  • Length: 5 Meter
A012230

  • Hypoallergenic skin adhesive tape

ASIA MED - 04251282509125

asia-med Kinesiology Tape - Light Green: made of cotton fabric with a medical grade acrylic adhesive applied in a wave pattern. Flexibility in longitudinal direction: approx. 60% (1:1,6)|Size: length 5 m, width 5 cm|Color: Light Green|Sales unit: 1 roll
asia-med GmbH
TAPE LIGHT GREEN, 5M X 5CM
In Commercial Distribution

  • 04251282509125 ()

  • Width: 5 Centimeter
  • Length: 5 Meter
A012231

  • Hypoallergenic skin adhesive tape

ASIA MED - 04251282504571

asia-med Kinesiology Tape - Light Purple: made of cotton fabric with a medical grade acrylic adhesive applied in a wave pattern. Flexibility in longitudinal direction: approx. 60% (1:1,6)|Size: length 5 m, width 5 cm|Color: Light Purple|Sales unit: 1 roll
asia-med GmbH
TAPE LIGHT PURPLE, 5M X 5CM
In Commercial Distribution

  • 04251282504571 ()

  • Width: 5 Centimeter
  • Length: 5 Meter
A012163

  • Hypoallergenic skin adhesive tape

ASIA MED - 04251282504564

asia-med Kinesiology Tape - Hot Green: made of cotton fabric with a medical grade acrylic adhesive applied in a wave pattern. Flexibility in longitudinal direction: approx. 60% (1:1,6)|Size: length 5 m, width 5 cm|Color: Hot Green|Sales unit: 1 roll
asia-med GmbH
TAPE HOT GREEN, 5M X 5CM
In Commercial Distribution

  • 04251282504564 ()

  • Width: 5 Centimeter
  • Length: 5 Meter
A012232

  • Hypoallergenic skin adhesive tape

Pointe Creatinine, Enzymatic Reagent - 00811727016072

Pointe Creatinine, Enzymatic Reagent packaged for use on the Mindray BA800. 3 x 60ml R1, 3 x 20ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
16-C7548-240
In Commercial Distribution

  • 00811727016072 ()
16-C7548-240

  • Creatinine IVD, kit, enzyme spectrophotometry

LD-Oxy - B322D0011

To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
LD TECHNOLOGY, LLC
D001
In Commercial Distribution

  • B322D0011 ()


  • Pulse oximeter, line-powered
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