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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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PROTEIN SEPARATION USING CAPILLARYS 3
SEBIA
2503
In Commercial Distribution

  • 03607360025031 ()
2503

  • Protein electrophoresis IVD, kit, electrophoresis
CARBOHYDRATE DEF TRANSFERRIN BY CE MINICAP
SEBIA
2228
In Commercial Distribution

  • 03607360022283 ()
2228

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
CAPILLARYS 3 WASH SOLUTION IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K161928.
SEBIA
2062
In Commercial Distribution

  • 03607360020623 ()
2062

  • Wash/cleaning solution IVD, automated/semi-automated system
AQUAbase nX 750HT (60Hz/208-220V)
B.Braun Avitum AG
LA1101376
In Commercial Distribution

  • 04046955725175 ()
LA1101376

  • Reverse-osmosis water purification system
AQUAbase® nX HT 500 Reverse Osmosis System
B.Braun Avitum AG
LA1101351
In Commercial Distribution

  • 04046955725168 ()
LA1101351

  • Reverse-osmosis water purification system
AQUAbase® nX HT 250 Reverse Osmosis System
B.Braun Avitum AG
LA1101326
In Commercial Distribution

  • 04046955725151 ()
LA1101326

  • Reverse-osmosis water purification system
NEXIVA 22GA X 1.75 IN SP WITH MAXZERO
BECTON, DICKINSON AND COMPANY
383553
In Commercial Distribution

  • 30382903835530 ()
  • 00382903835539 ()
  • 50382903835534 ()

  • Flow Rate = 30 millilitre per minute (mL or ml/min)
  • Length: 45 Millimeter
383553

  • Peripheral intravenous cannula
NDL SP S/SU 25GA 4-11/16IN WHITACRE CE
BECTON, DICKINSON AND COMPANY
400372
In Commercial Distribution

  • 30382904003723 ()
  • 00382904003722 ()
  • 50382904003727 ()

  • Length: 119.1 Millimeter
  • Needle Gauge: 25 Gauge
400372

  • Spinal needle, single-use
NDL SP S/SU 27GA 4-11/16IN WHITACRE CE
BECTON, DICKINSON AND COMPANY
400371
In Commercial Distribution

  • 50382904003710 ()
  • 30382904003716 ()
  • 00382904003715 ()

  • Length: 119.1 Millimeter
400371

  • Spinal needle, single-use
OUTER CANISTER, SOFT LINER, 1000CC
MEDLINE INDUSTRIES, INC.
DYNDCLO1000
In Commercial Distribution

  • 10080196140183 ()
  • 40080196140184 ()
DYNDCLO1000

  • Suction/irrigation system canister/bottle holder, reusable
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