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 Class Implantable

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No Description
BIOTRONIK SE & Co. KG
1702.U
Not in Commercial Distribution

  • 04035479157678 ()
431886

  • Cardiac pulse generator programmer
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
No Description
BIOTRONIK SE & Co. KG
1506.U/1
Not in Commercial Distribution

  • 04035479154165 ()
421374

  • Cardiac pulse generator programmer
No Description
BIOTRONIK SE & Co. KG
2201.U/1
Not in Commercial Distribution

  • 04035479178024 ()
472134

  • Cardiac pulse generator programmer
No Description
BIOTRONIK SE & Co. KG
2201.U/1
Not in Commercial Distribution

  • 04035479178017 ()
472133

  • Cardiac pulse generator programmer
No Description
BIOTRONIK SE & Co. KG
MyHomeStream 2100.U
In Commercial Distribution

  • 04035479177416 ()
469255

  • Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
HomeStreamCP 2100.U
In Commercial Distribution

  • 04035479177409 ()
469254

  • Implantable electrical stimulation device management software
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
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