BICARBOLYTE HEMO-DIAL
EDLAW PHARMACEUTICALS, INC.
EDLAW PHARMACEUTICALS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2431908 | 2431908 | EDLAW PHARMACEUTICALS, INC. | 1 | N | 2026-01-01 | 195-B CENTRAL AVE. E Farmingdale NY US 11735 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00857940006674 | Hemo-Dial - 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 | 631-454-6888 | edlawpharm@optonline.net |
| 00857940006681 | Hemo-Dial - 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 | 631-454-6888 | edlawpharm@optonline.net |
| 10857940006015 | Hemo-Dial - POTASSIUM CHLORIDE 5.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM | 631-454-6888 | edlawpharm@optonline.net |
| 10857940006022 | Hemo-Dial - POTASSIUM CHLORIDE 11.5 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM | 631-454-6888 | edlawpharm@optonline.net |
| 10857940006039 | Hemo-Dial - POTASSIUM CHLORIDE 23 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/LITER INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM | 631-454-6888 | edlawpharm@optonline.net |
| 10857940006596 | Hemo-Dial - CALCIUM CHLORIDE 3.1 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.25 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM | 631-454-6888 | edlawpharm@optonline.net |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 37250 | 1339655036 | K813388 | HEMODIALYSATE | KPO | 1981-12-31 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KPO | 1 | 1981-12-31 |
PMN#
HEMODIALYSATE
EDLAW PHARMACEUTICALS, INC.
LACTIC ACID DIALYSATE ADDITIVE
EDLAW PHARMACEUTICALS, INC.
GUDID#
Hemo-Dial - 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
2022-02-24
Hemo-Dial - 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
2022-02-24
Hemo-Dial - 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
2022-02-24
Hemo-Dial - 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
2022-02-24
Hemo-Dial - CALCIUM CHLORIDE 3.1 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.25 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - POTASSIUM CHLORIDE 5.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - POTASSIUM CHLORIDE 11.5 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - POTASSIUM CHLORIDE 23 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/LITER INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - POTASSIUM CHLORIDE 13.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/LITER INCREASE WHEN ADDED TO 8 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - POTASSIUM CHLORIDE 26.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/LITER INCREASE WHEN ADDED TO 8 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 2.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.25 mEq/L INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 5.7 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 11.3 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 3.43 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 6.3 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 12.5 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 25 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 13.2 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 8 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 26.4 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 8 LITERS IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 15.6 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 9.46 LITERS (2.5 GALLONS) IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 31.3 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 9.46 LITERS (2.5 GALLONS) IN A 45X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - 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
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 5.1 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 36.83X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 10.2 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 36.83X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 20.5 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 2 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 36.83X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 12.8 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 9.46 LITERS (2.5 GALLONS) IN A 36.83X PROPORTIONING SYSTEM
2016-09-23
Hemo-Dial - CALCIUM CHLORIDE USP 25.6 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 1 mEq/L INCREASE WHEN ADDED TO 9.46 LITERS (2.5 GALLONS) IN A 36.83X PROPORTIONING SYSTEM
2016-09-23