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

  • 40383790008868 ()
  • 00383790008860 ()


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

  • 00763000241483 ()


  • Stereotactic surgery system workstation
The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal IX V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
Philips Medical Systems Nederland B.V.
6.5
Not in Commercial Distribution

  • 00884838083653 ()


  • CT system workstation
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