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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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Nephros SSUmini JG UltraFiltro - 00896241002626

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

DIASAFE®plusUS - 00840861102136

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® - 04046963178116

DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter

Synergy - 00613994532398

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

  • 00613994532398 ()


  • Stereotactic surgery system workstation

Stealthstation® S7™ - 00613994792921

PLNG STATION 9734669R RWK S7
MEDTRONIC NAVIGATION, INC.
9734669R
In Commercial Distribution

  • 00613994792921 ()


  • Stereotactic surgery system workstation

NA - 00643169777316

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

  • 00643169777316 ()


  • Stereotactic surgery system workstation

Filter for dialysate purification - 04987671030214

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

Nipro Ultrafilter - 00383790008860

Filter for clean dialysate and water
NIPRO MEDICAL CORPORATION
CF+609N
In Commercial Distribution

  • 40383790008868 ()
  • 00383790008860 ()


  • Haemodialysis system dialysate pyrogen filter

StealthStation® AXIEM™ System - 00763000241483

AXIEM KIT 9732750 PORTABLE PRE-BUILD
MEDTRONIC NAVIGATION, INC.
9732750
In Commercial Distribution

  • 00763000241483 ()


  • Stereotactic surgery system workstation

StealthStation® AXIEM™ System - 00613994109477

AXIEM KIT, 9732750, PORTABLE PRE-BUILD
MEDTRONIC NAVIGATION, INC.
9732750
In Commercial Distribution

  • 00613994109477 ()


  • Stereotactic surgery system workstation
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