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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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2008® Series Hemodialysis Machines - 00840861100927

2008T GEN 2 BIBAG WITHOUT CDX
Fresenius Usa, Inc.
190895
In Commercial Distribution

  • 00840861100927 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100910

2008T HEMODIALYSIS SYSTEM W/CDX W/BIBAG
Fresenius Usa, Inc.
190766
In Commercial Distribution

  • 00840861100910 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100903

2008T HEMODIALYSIS SYSTEM WITHOUT CDX
Fresenius Usa, Inc.
190858
In Commercial Distribution

  • 00840861100903 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100897

2008T HEMODIALYSIS SYS., with CDX
Fresenius Usa, Inc.
190713
In Commercial Distribution

  • 00840861100897 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100873

2008K2 HEMO SYSTEM, OPTIONAL 5th MODULE
Fresenius Usa, Inc.
190633
In Commercial Distribution

  • 00840861100873 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100866

2008K2 MACHINE, SHORT CAB, OLC/DP, HP
Fresenius Usa, Inc.
190630
In Commercial Distribution

  • 00840861100866 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100859

2008K2 HEMODIALYSIS SYS. OLC/ DIASAFE PLS
Fresenius Usa, Inc.
190610
In Commercial Distribution

  • 00840861100859 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100965

2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
Fresenius Usa, Inc.
190904
In Commercial Distribution

  • 00840861100965 ()


  • Haemodialysis system, institutional/home-use

2008® Series Hemodialysis Machines - 00840861100958

2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP
Fresenius Usa, Inc.
190395
In Commercial Distribution

  • 00840861100958 ()


  • Haemodialysis system, institutional/home-use

2008® Series Hemodialysis Machines - 00840861100941

2008K@HOME HEMODIALYSIS SYSTEM
Fresenius Usa, Inc.
190828
In Commercial Distribution

  • 00840861100941 ()


  • Haemodialysis system, institutional/home-use
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