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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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SmartInfuser Set, 5-15ml/hr, with MultiBolus - 05707480119929

Regulating Set 5-15 with MultiBolus, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)
Ambu A/S
418000519
In Commercial Distribution

  • 05707480119936 ()
  • 05707480119929 ()


  • Elastomeric infusion pump kit

SmartInfuser Set, 1-6ml/hr, with MultiBolus - 05707480119370

Regulating Set 1-6 with MultiBolus, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)
Ambu A/S
418000511
In Commercial Distribution

  • 05707480119387 ()
  • 05707480119370 ()


  • Elastomeric infusion pump kit

LiNA OperaScope™ with HDMI cable - 05708265013388

LiNA OperaScope™ with HDMI cable, without on-board LCD screen, intended for hysteroscopy and cystoscopy
Lina Medical ApS
OP-200-6
In Commercial Distribution

  • 05708265013395 ()
  • 05708265013388 ()


  • Rigid video hysteroscope

LiNA OperaScope™ with HDMI cable - 05708265012374

LiNA OperaScope™ with HDMI cable, without on-board LCD screen, intended for hysteroscopy and cystoscopy
Lina Medical ApS
OP-200-6
Not in Commercial Distribution

  • 05708265012381 ()
  • 05708265012374 ()


  • Rigid video hysteroscope

LiNA OperaScope™ with HDMI cable - 05708265010264

LiNA OperaScope™ with HDMI cable, without on-board LCD screen
Lina Medical ApS
OP-200-6
Not in Commercial Distribution

  • 05708265010264 ()
  • 05708265010271 ()


  • Rigid video hysteroscope

Hemolung® Cartridge with Blood Tubing - 00850046004254

Hemolung® Cartridge with Blood Tubing
Alung Technologies, Inc.
40400
Not in Commercial Distribution

  • 00850046004254 ()


  • Mobile extracorporeal gas exchange system

CHANG Medium® D with Antibiotics - 00857515006030

CHANG Medium® D with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
99404-500mL
Not in Commercial Distribution

  • 00857515006030 ()

  • Total Volume: 500 Milliliter
99404

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

microTargeting™ Insertion Tube with Stylet - 00873263008676

microTargeting Insertion Tube with Stylet, Sterile
FHC, INC.
66-IT-AO11P-00867
In Commercial Distribution

  • 10873263008673 ()
  • 00873263008676 ()
66-IT-AO11P

  • Intracerebral cannula, nonimplantable, single-use

microTargeting™ Insertion Tube with Stylet - 00873263008423

2.0mm O.D Insertion Tube with Stylet 127.1 mm
FHC, INC.
66-IT-SG1P-00842
In Commercial Distribution

  • 10873263008420 ()
  • 00873263008423 ()
66-IT-SG1P

  • Intracerebral cannula, nonimplantable, single-use

microTargeting™ Insertion Tube with Stylet - 00873263008218

microTargeting™ Insertion Tube with Stylet, sterile
FHC, INC.
66-IT-15P-00821
In Commercial Distribution

  • 10873263008215 ()
  • 00873263008218 ()
66-IT-15P

  • Intracerebral cannula, nonimplantable, single-use
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