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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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Dialysate Sack (SAK) with Concentrate - M535SAK3010

No Description
NXSTAGE MEDICAL, INC.
SAK-301
In Commercial Distribution

  • M535SAK3015 ()
  • M535SAK3010 ()


  • Haemodialysis concentrate

NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP - M535CAR5350

No Description
NXSTAGE MEDICAL, INC.
CAR-535
In Commercial Distribution

  • M535CAR5355 ()
  • M535CAR5350 ()


  • Haemodialysis/haemofiltration system component set

H-Pette with Blade (1000 pieces) - M52536120

No Description
HELENA LABORATORIES CORPORATION
3612
In Commercial Distribution

  • M52536120 ()


  • Blood/blood culture specimen transfer spike IVD, manual

Dialysate Sack (SAK) with Concentrate - M535SAK407A0

No Description
NXSTAGE MEDICAL, INC.
SAK-407-A
In Commercial Distribution

  • M535SAK407A5 ()
  • M535SAK407A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK4070

No Description
NXSTAGE MEDICAL, INC.
SAK-407
In Commercial Distribution

  • M535SAK4075 ()
  • M535SAK4070 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK406A0

No Description
NXSTAGE MEDICAL, INC.
SAK-406-A
In Commercial Distribution

  • M535SAK406A5 ()
  • M535SAK406A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK4060

No Description
NXSTAGE MEDICAL, INC.
SAK-406
In Commercial Distribution

  • M535SAK4065 ()
  • M535SAK4060 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK405A0

No Description
NXSTAGE MEDICAL, INC.
SAK-405-A
In Commercial Distribution

  • M535SAK405A5 ()
  • M535SAK405A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK4050

No Description
NXSTAGE MEDICAL, INC.
SAK-405
In Commercial Distribution

  • M535SAK4055 ()
  • M535SAK4050 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK404A0

No Description
NXSTAGE MEDICAL, INC.
SAK-404-A
In Commercial Distribution

  • M535SAK404A5 ()
  • M535SAK404A0 ()


  • Haemodialysis concentrate
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