EDLAW PHARMACEUTICALS, INC.

Address:195-B CENTRAL AVE.,E Farmingdale,NY,11735,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (KPO) (10)

Premarket Exempt

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Hemo-Dial - 10857940006015 Catalog Number : P58BX

Device Description : POTASSIUM CHLORIDE 5.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER INC POTASSIUM CHLORIDE 5.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 150

Hemo-Dial - 10857940006022 Catalog Number : P115BX

Device Description : POTASSIUM CHLORIDE 11.5 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCR POTASSIUM CHLORIDE 11.5 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 125

Hemo-Dial - 10857940006039 Catalog Number : P23BX

Device Description : POTASSIUM CHLORIDE 23 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/LITER INCREA POTASSIUM CHLORIDE 23 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/LITER INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 90

Hemo-Dial - 10857940006046 Catalog Number : P63BX

Device Description : POTASSIUM CHLORIDE 6.3 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER INC POTASSIUM CHLORIDE 6.3 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 150

Hemo-Dial - 10857940006053 Catalog Number : P127BX

Device Description : POTASSIUM CHLORIDE 12.7 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCR POTASSIUM CHLORIDE 12.7 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 100

Hemo-Dial - 10857940006060 Catalog Number : P254BX

Device Description : POTASSIUM CHLORIDE 25.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/LITER INCR POTASSIUM CHLORIDE 25.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/LITER INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 90

Hemo-Dial - 10857940006077 Catalog Number : P134BX

Device Description : POTASSIUM CHLORIDE 13.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER IN POTASSIUM CHLORIDE 13.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER INCREASE WHEN ADDED TO 8 LITERS IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 100

Hemo-Dial - 10857940006084 Catalog Number : P268BX

Device Description : POTASSIUM CHLORIDE 26.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCR POTASSIUM CHLORIDE 26.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCREASE WHEN ADDED TO 8 LITERS IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 90

Hemo-Dial - 10857940006091 Catalog Number : P159BX

Device Description : POTASSIUM CHLORIDE 15.9 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER IN POTASSIUM CHLORIDE 15.9 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER INCREASE WHEN ADDED TO 9.46 LITERS (2.5 GALLONS) IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 100

Hemo-Dial - 10857940006107 Catalog Number : P317bx

Device Description : POTASSIUM CHLORIDE 31.7 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCR POTASSIUM CHLORIDE 31.7 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCREASE WHEN ADDED TO 9.46 LITERS (2.5 GALLONS) IN A 45X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 50

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