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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 - M535SAK3020

No Description
NXSTAGE MEDICAL, INC.
SAK-302
In Commercial Distribution

  • M535SAK3025 ()
  • M535SAK3020 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK301A0

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

  • M535SAK301A5 ()
  • M535SAK301A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3010

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

  • M535SAK3015 ()
  • M535SAK3010 ()


  • Haemodialysis concentrate

Hemo-Dial - 10857940006688

CALCIUM CHLORIDE USP 9.4 GRAMS - HEMODIALYSATE ADDITIVE - 0.75 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM
EDLAW PHARMACEUTICALS, INC.
C94BX
In Commercial Distribution

  • 00857940006681 ()
  • 10857940006688 ()

  • Weight: 3.9 Pound
C94BX

  • Haemodialysis concentrate

Hemo-Dial - 10857940006671

CALCIUM CHLORIDE USP 3.1 GRAMS - HEMODIALYSATE ADDITIVE - 0.25 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM
EDLAW PHARMACEUTICALS, INC.
C31BX
In Commercial Distribution

  • 00857940006674 ()
  • 10857940006671 ()

  • Weight: 3.0 Pound
C31BX

  • Haemodialysis concentrate

HEMO-DIAL - 10857940006664

CALCIUM CHLORIDE 2.2 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.25 mEq/L INCREASE WHEN ADDED TO 3.43 LITERS IN A 35X PROPORTIONING SYSTEM
EDLAW PHARMACEUTICALS, INC.
C22BX
In Commercial Distribution

  • 10857940006664 ()
  • 00857940006667 ()

  • Weight: 2.4 Pound
C22BX

  • Haemodialysis concentrate

Hemo-Dial - 10857940006657

CALCIUM CHLORIDE 18.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1.5mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM
EDLAW PHARMACEUTICALS, INC.
C188BX
In Commercial Distribution

  • 10857940006657 ()
  • 00857940006650 ()

  • Weight: 5.4 Pound
C188BX

  • Haemodialysis concentrate

Hemo-Dial - 10857940006640

ASCORBIC ACID 2.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - USED FOR CHLORAMINE REDUCTION
EDLAW PHARMACEUTICALS, INC.
A28BX
In Commercial Distribution

  • 10857940006640 ()
  • 00857940006643 ()

  • Weight: 2.9 Pound
A28BX

  • Haemodialysis concentrate

Hemo-Dial - 10857940006633

POTASSIUM CHLORIDE USP 19 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1.5 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM
EDLAW PHARMACEUTICALS, INC.
P19BX
In Commercial Distribution

  • 10857940006633 ()
  • 00857940006636 ()

  • Weight: 6.1 Pound
P19BX

  • Haemodialysis concentrate

Hemo-Dial - 10857940006626

POTASSIUM CHLORIDE USP 6.4 GRAM PACKETS
EDLAW PHARMACEUTICALS, INC.
P64BX
Not in Commercial Distribution

  • 10857940006626 ()
  • 00857940006629 ()

  • Weight: 4.1 Pound
P64BX

  • Haemodialysis concentrate
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