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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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Diacap® - 04046963178116

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

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter

Diasafe - 04039361001384

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® - 04039239090496

Diacap® Ultra Dialysis Fluid Filters
B.Braun Avitum AG
7107367
Not in Commercial Distribution

  • 04039239090496 ()
  • 04039239090489 ()
7107367

  • 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

Geniant Cranial - 08800050902666

Planning Workstation (US)
KOH YOUNG TECHNOLOGY INC.
KY-PWS-0030-B
In Commercial Distribution

  • 08800050902666 ()


  • Stereotactic surgery system workstation

Nipro Ultrafilter - 00383790008860

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

  • 40383790008868 ()
  • 00383790008860 ()


  • Haemodialysis system dialysate pyrogen filter

MarCor ENX Hollow Fiber Capsule UltraFilter - 00896241002732

The MarCor ENX Hollow Fiber Capsule UltraFilter 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.). Use: The device is intended for long term continuous use. Once it completes its useful life, the filter should be replaced and discarded. Do not attempt to sterilize or reuse it. CONTRAINDICATIONS Medical: While the MarCor ENX produces ultrapure water, the water is not intended to be used in medical applications where USP sterile water is normally used. Chemical: The MarCor ENX retains biological contaminants. To obtain chemically pure water it is necessary to use the filter in conjunction with other devices such as DI beds or RO systems.
NEPHROS, INC.
W2T912244
In Commercial Distribution

  • 00896241002732 ()
  • 10896241002739 ()
  • 20896241002736 ()
70-0251M

  • Haemodialysis system dialysate pyrogen filter

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

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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