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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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MaxGuard - 10885403237577

Extension set, with 2 needleless Y-sites 22 cm (8.5 in)
BD Switzerland Sàrl
MX9037
In Commercial Distribution

  • 20885403237574 ()
  • 10885403237577 ()
  • 50885403237575 ()

  • Length: 8.5 Inch
MX9037

  • Intravenous administration tubing extension set

MaxGuard, MaxPlus - 10885403237058

Extension Set, (minibore) with Needleless Connector 36 cm (14 in)
BD Switzerland Sàrl
MP9229
In Commercial Distribution

  • 20885403237055 ()
  • 10885403237058 ()
  • 50885403237056 ()

  • Length: 14 Inch
MP9229

  • Intravenous administration tubing extension set

Outlook® - 04046964182259

60 drops/mL, Priming volume: 25 mL, Length: 120 in.
B. BRAUN MEDICAL INC.
354215
In Commercial Distribution

  • 04046964182259 ()
  • 04046964182242 ()
354215

  • Electric infusion pump administration set, single-use

Base It - 08809262954524

Light-cured base/liner containing calcium hydroxyapatite in urethane methacrylate oligomer.
Spident Co., Ltd.
101-0101
In Commercial Distribution

  • 08809262954524 ()
  • 20200106170421 ()
  • 00000202209089 ()
101-0101

  • Dental composite resin

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

Sirrus® Total Protein LiquiColor® - 00657498001509

For the Quantitative Colorimetric Determination of Total Protein in Serum.
STANBIO LABORATORY, L.P.
S0250-750
In Commercial Distribution

  • 00657498001509 ()
S0250-750

  • Total protein IVD, kit, spectrophotometry

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
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