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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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Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KP-05
In Commercial Distribution

  • 14537693900636 ()
  • 04537693900639 ()


  • Apheresis system filter, whole blood
Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
NK-M3R(UL)
In Commercial Distribution

  • 18855036020688 ()
  • 28855036020685 ()


  • Apheresis system tubing set
Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
NK-M3R(U)
In Commercial Distribution

  • 18855036012850 ()
  • 28855036012857 ()


  • Apheresis system tubing set
Nitrile disposable powder-free examination gloves with thickness 4.7-5.3 mil, 100 gloves per box. Medical Grade, Chemotherapy drug tested, Not made with Rubber Latex, Low Derma, Protection against Fentanyl, Single use, Non-sterile. Size is Medium.
Armstrong Medical Supply, LLC
AMSDEF5-M
In Commercial Distribution

  • 00850031575202 ()
  • 00850031575141 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders with 12 cm long preconnect tubing
BOSTON SCIENTIFIC CORPORATION
72404233-12
In Commercial Distribution

  • 00878953009797 ()

  • Outer Diameter: 12 Millimeter
  • Length: 21 Centimeter


  • Inflatable penile prosthesis
ZOLL FULLY AUTOMATIC AED PLUS WITH PRESCRIPTION, CPR D PADZ, 10 CR123A BATTERIES, AND CARRY CASE
Zoll Medical Corporation
8000-004007-01
In Commercial Distribution

  • 00847946056568 ()


  • Non-rechargeable public semi-automated external defibrillator
Lithium sulfur dioxide battery for use with Cardiac Science(TM) G5 models G5A-80A, G5A-80C, G5S-80A, G5S-80C
AED BATTERY EXCHANGE, LLC
G5-ABE
In Commercial Distribution

  • 00864312000284 ()


  • Disposable battery pack
Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders with 14 cm long preconnect tubing
BOSTON SCIENTIFIC CORPORATION
72404234-14
In Commercial Distribution

  • 00878953009803 ()

  • Outer Diameter: 12 Millimeter
  • Length: 24 Centimeter


  • Inflatable penile prosthesis
Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders with 10 cm long preconnect tubing
BOSTON SCIENTIFIC CORPORATION
72404232-10
In Commercial Distribution

  • 00878953009780 ()

  • Outer Diameter: 12 Millimeter
  • Length: 18 Centimeter


  • Inflatable penile prosthesis
Powerheart® G5 AED, Automatic (US English/LA Spanish) with Intellisense Adult Electrodes and TSO Battery
Zoll Medical Corporation
G5A-80A-TSO
In Commercial Distribution

  • 00812394021390 ()
G5A-80A-TSO

  • Non-rechargeable public automated external defibrillator
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