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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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Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies.
GAMBRO DASCO SPA
6023006700
Not in Commercial Distribution

  • 07332414042035 ()
103453

  • Haemodialysis system dialysate delivery unit
No Description
SEBIA
4767
In Commercial Distribution

  • 03607360047675 ()
4767

  • Glycated haemoglobin (HbA1c) IVD, control
No Description
SEBIA
4139
In Commercial Distribution

  • 03607360041390 ()
4139

  • Protein electrophoresis IVD, kit, electrophoresis
Lipoprotein + Lp(a) using K20
SEBIA
3007
In Commercial Distribution

  • 03607360030073 ()
3007

  • Protein electrophoresis IVD, kit, electrophoresis
No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent
CAPILLARYS 3 URINE KIT IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K192095
SEBIA
2513
In Commercial Distribution

  • 03607360025130 ()
2513

  • Protein electrophoresis IVD, kit, electrophoresis
MINICAP PROTEIN MAXI KIT
SEBIA
2223
In Commercial Distribution

  • 03607360022238 ()
2223

  • Protein electrophoresis IVD, kit, electrophoresis
CARBOHYDRATE DEF TRANSFERRIN BY MINICAP CE
SEBIA
2208
In Commercial Distribution

  • 03607360022085 ()
2208

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
PROTEIN SEPERATION BY MINICAP
SEBIA
2203
In Commercial Distribution

  • 03607360022030 ()
2203

  • Protein electrophoresis IVD, kit, electrophoresis
CAPILLARYS /MINICAP WASH SOLUTION IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K082085.
SEBIA
2052
In Commercial Distribution

  • 03607360020524 ()
2052

  • Wash/cleaning solution IVD, automated/semi-automated system
CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT
SEBIA
2029
In Commercial Distribution

  • 03607360020296 ()
2029

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
CARBOHYDRATE DEF TRANSFERRING BY CE
SEBIA
2009
In Commercial Distribution

  • 03607360020098 ()
2009

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
PROTEIN SEPARATION USING CAPILLARY ELECTROPHORESIS
SEBIA
2003
In Commercial Distribution

  • 03607360020036 ()
2003

  • Protein electrophoresis IVD, kit, electrophoresis
Integra® Miltex® CryoSolutions® Complete Set, 1mm Standard Tip(33511), 1 Cartridge(33518)(23.5g N2O) and 1 Metal Pin(33520)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
33510
In Commercial Distribution

  • H834335101 ()
  • 10381780171898 ()
33510

  • General cryosurgical system, cryogen gas, mechanical
CONSOLE 106A3 GEN V ROHS PLX
Medtronic CryoCath LP
106A3
In Commercial Distribution

  • 00763000486778 ()


  • Cardiac cryosurgical system
CONSOLE 106A3 GEN V ROHS PLX
MEDTRONIC, INC.
106A3
In Commercial Distribution

  • 00763000011147 ()


  • Cardiac cryosurgical system
BLOOD CULTURE, LUER LOCK ACCESS DEVICE
MEDLINE INDUSTRIES, INC.
BCLLAD
In Commercial Distribution

  • 30193489189654 ()
  • 10193489189650 ()
  • 20193489189657 ()
BCLLAD

  • Blood collection set, invasive
BLOOD CULTURE, TUBE HOLDER
MEDLINE INDUSTRIES, INC.
BCTHLDR
In Commercial Distribution

  • 30193489189661 ()
  • 20193489189664 ()
  • 10193489189667 ()
BCTHLDR

  • Blood collection set, invasive
BLOOD CULTURE, TRANSFER DEVICE
MEDLINE INDUSTRIES, INC.
BCBTRD
In Commercial Distribution

  • 20193489189640 ()
  • 30193489189647 ()
  • 10193489189643 ()
BCBTRD

  • Blood collection set, invasive
The POWERWAND™ XL Introducer with Extended Dwell Catheter, 4Fr x 10cm
ACCESS SCIENTIFIC, LLC
Alternate Site Kit 4Fr x 10cm
In Commercial Distribution

  • 00859821006681 ()

  • Pressure: 325 Pound per Square Inch
  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter
  • Catheter Gauge: 4 French
80701

  • Peripheral vascular catheter
Soothe-Guard® Adult Pano Cape .35mm - Charcoal
Dentsply International Inc.
662305300
In Commercial Distribution

  • D0036623053001 ()
662305300

  • Radiation shielding apron
Soothe-Guard® Adult Apron with Collar .35mm - Charcoal
Dentsply International Inc.
662305000
In Commercial Distribution

  • D0036623050001 ()
662305000

  • Radiation shielding apron
Soothe-Guard® Adult Apron w/o Collar .35mm - Charcoal
Dentsply International Inc.
662304902
In Commercial Distribution

  • D0036623049021 ()
662304902

  • Radiation shielding apron
Soothe-Guard® Adult Apron with Collar .35mm - Royal Blue
Dentsply International Inc.
662205000
In Commercial Distribution

  • D0036622050001 ()
662205000

  • Radiation shielding apron
Soothe-Guard® Adult Apron w/o Collar .35mm - Royal Blue
Dentsply International Inc.
662204902
In Commercial Distribution

  • D0036622049021 ()
662204902

  • Radiation shielding apron
Soothe-Guard® Child Apron with Collar .35mm - Royal Blue
Dentsply International Inc.
662204700
In Commercial Distribution

  • D0036622047001 ()
662204700

  • Radiation shielding apron
Soothe-Guard® Adult Apron with Collar .35mm - Sand
Dentsply International Inc.
662105000
In Commercial Distribution

  • D0036621050001 ()
662105000

  • Radiation shielding apron
Soothe-Guard® Adult Apron w/o Collar .35mm - Sand
Dentsply International Inc.
662104902
In Commercial Distribution

  • D0036621049021 ()
662104902

  • Radiation shielding apron
Soothe-Guard® Adult Pano Cape .35mm - Cool Grey
Dentsply International Inc.
662005300
In Commercial Distribution

  • D0036620053001 ()
662005300

  • Radiation shielding apron
Soothe-Guard® Adult Apron with Collar .35mm - Cool Grey
Dentsply International Inc.
662005000
In Commercial Distribution

  • D0036620050001 ()
662005000

  • Radiation shielding apron
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