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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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ACTion Fuser Pump, 200ml, 1-6 ml/hr140mm caut-to-size catheter, 4" int - 05707480121472

ACTion Fuser 200,1-6 ml/hr,140mm Cut-to-size,prosit, 3.25"In
Ambu A/S
418111200
In Commercial Distribution

  • 05707480121595 ()
  • 05707480121472 ()

  • Total Volume: 300 Milliliter
  • Total Volume: 200 Milliliter
  • Length: 140 Millimeter
418111200

  • Elastomeric infusion pump kit

IDG/Sanzay - 00850053916090

For the quantitative determination of Creatine Kinase in human serum.
IDG/SANZAY Corporation
1
In Commercial Distribution

  • 00850053916090 ()

  • Total Volume: 150 Milliliter
  • Total Volume: 1 Liter
C153

  • Total creatine kinase (CK) IVD, reagent

RELION - 00681131060240

RELION 60 SEC DIG THERM W/BEEPER FAHRE IN BOX
WAL-MART STORES, INC.
144-691-000
In Commercial Distribution

  • 10681131060247 ()
  • 30681131060241 ()
  • 00681131060240 ()
144-691-000

  • Continuous electronic patient thermometer, battery-powered

MagPro Accessories - 05713484030696

Cable accessories for MagPro, approved with MagPro R30 in K061645.
Tonica Elektronik A/S
Cable for Ext. Trig with D-sub
In Commercial Distribution

  • 05713484030696 ()
9016E4551

  • Magnetic neural stimulation system

Sirrus® Creatinine LiquiColor® - 00657498001554

For the Quantitative Determination of Creatinine in Serum and Urine.
STANBIO LABORATORY, L.P.
S0430-600
In Commercial Distribution

  • 00657498001554 ()
S0430-600

  • Creatinine IVD, kit, enzyme spectrophotometry

Sirrus® Direct Gylcohemoglobin (HbA1c) - 00657498001523

For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood.
STANBIO LABORATORY, L.P.
S0360-200
In Commercial Distribution

  • 00657498001523 ()
S0360-200

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Cyanmethemoglobin Standard (20 gm/dL @ 1:251 DILUTION) - 00657498001158

For the Quantitative Colorimetric Determination of Hemoglobin in Whole Blood.
STANBIO LABORATORY, L.P.
0325-006
Not in Commercial Distribution

  • 00657498001158 ()
0325-006

  • Cyanomethemoglobin kit

Total Protein LiquiColor® - 00657498000991

For the Quantitative Colorimetric Determination of Total Protein in Serum.
STANBIO LABORATORY, L.P.
0250-500
In Commercial Distribution

  • 00657498000991 ()
0250-500

  • Total protein IVD, kit, spectrophotometry

Potassium Test - 00657498000984

Quantitative Turbidimetric Determination of Potassium in Serum, Plasma or Urine .
STANBIO LABORATORY, L.P.
0160-050
In Commercial Distribution

  • 00657498000984 ()
0160-050

  • Potassium (K+) IVD, reagent

Glycohemoglobin Bi-Level Controls - 00657498000922

For Use as Human Glycohemoglobin Controls in Quantitative Glycohemoglobin Procedures.
STANBIO LABORATORY, L.P.
0357-201
In Commercial Distribution

  • 00657498000922 ()
0357-201

  • Total haemoglobin (totHb) IVD, control
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