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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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PLNG STATION 9734048 STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048
In Commercial Distribution

  • 00613994532398 ()


  • Stereotactic surgery system workstation
PLNG STATION 9734048R STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048R
In Commercial Distribution

  • 00643169777316 ()


  • Stereotactic surgery system workstation
The Nephros SSUmini JG UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0251P
In Commercial Distribution

  • 10896241002623 ()
  • 00896241002626 ()
  • 20896241002620 ()


  • Haemodialysis system dialysate pyrogen filter
FILTER, DIASAFE PLUS
Fresenius Medical Care AG
5008201
In Commercial Distribution

  • 04039361001391 ()
  • 04039361001384 ()

  • Area/Surface Area: 2.2 Square meter
5008203

  • Haemodialysis system dialysate pyrogen filter
Diacap® Ultra Dialysis Fluid Filters
B.Braun Avitum AG
7107367
Not in Commercial Distribution

  • 04039239090496 ()
  • 04039239090489 ()
7107367

  • Haemodialysis system dialysate pyrogen filter
No Description
Fresenius Medical Care Renal Therapies Group, LLC
F00007039
In Commercial Distribution

  • 10840861102133 ()
  • 00840861102136 ()

  • Area/Surface Area: 2.1 Square meter
F00007039

  • Haemodialysis system dialysate pyrogen filter
DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter
Planning Workstation (US)
KOH YOUNG TECHNOLOGY INC.
KY-PWS-0030-B
In Commercial Distribution

  • 08800050902666 ()


  • Stereotactic surgery system workstation
Filter for clean dialysate and water
NIPRO MEDICAL CORPORATION
CF+609N
In Commercial Distribution

  • 40383790008868 ()
  • 00383790008860 ()


  • Haemodialysis system dialysate pyrogen filter
The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The filter(s) are used as part of Hemodialysis machine hydraulic section.
NIKKISO CO.,LTD.
EF-02D
In Commercial Distribution

  • 24987671030218 ()
  • 04987671030214 ()


  • Haemodialysis system dialysate pyrogen filter
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