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 - 10857940006213 Catalog Number : P47BX

Device Description : POTASSIUM CHLORIDE USP 4.7 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INC POTASSIUM CHLORIDE USP 4.7 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 3.43 LITERS IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 175

Hemo-Dial - 10857940006220 Catalog Number : P94BX

Device Description : POTASSIUM CHLORIDE USP 9.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCRE POTASSIUM CHLORIDE USP 9.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 3.43 LITERS IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 125

Hemo-Dial - 10857940006237 Catalog Number : P188BX

Device Description : POTASSIUM CHLORIDE USP 18.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/L INCR POTASSIUM CHLORIDE USP 18.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/L INCREASE WHEN ADDED TO 3.43 LITERS IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 100

Hemo-Dial - 10857940006244 Catalog Number : P52BX

Device Description : POTASSIUM CHLORIDE 5.2 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREAS POTASSIUM CHLORIDE 5.2 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 3.78 LITER (1 GALLON) IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 150

Hemo-Dial - 10857940006251 Catalog Number : P104BX

Device Description : POTASSIUM CHLORIDE USP 10.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCR POTASSIUM CHLORIDE USP 10.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 125

Hemo-Dial - 10857940006268 Catalog Number : P208BX

Device Description : POTASSIUM CHLORIDE USP 20.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/L INCR POTASSIUM CHLORIDE USP 20.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (I GALLON) IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 90

Hemo-Dial - 10857940006282 Catalog Number : P13BX

Device Description : POTASSIUM CHLORIDE USP 13 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCR POTASSIUM CHLORIDE USP 13 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 9.46 LITERS (2.5 GALLONS) IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 100

Hemo-Dial - 10857940006299 Catalog Number : P26BX

Device Description : POTASSIUM CHLORIDE USP 26 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREA POTASSIUM CHLORIDE USP 26 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 9.46 LITERS (2.5 GALLONS) IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 90

Hemo-Dial - 10857940006305 Catalog Number : C46BX

Device Description : CALCIUM CHLORIDE USP 4.6 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCRE CALCIUM CHLORIDE USP 4.6 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 3.43 LITERS IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 200

Hemo-Dial - 10857940006312 Catalog Number : C93BX

Device Description : CALCIUM CHLORIDE USP 9.3 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREAS CALCIUM CHLORIDE USP 9.3 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 3.43 LITERS IN A 36.83X PROPORTIONING SYSTEM

Device Class :

Duns Number: 029646569

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 125

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