Label: LEUKOTRAP WB SYSTEM kit
- NDC Code(s): 53157-262-01
- Packager: Haemonetics Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 26, 2022
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- Official Label (Printer Friendly)
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DOSAGE & ADMINISTRATION
CP2D Anticoagulant Solution and AS-3 Solution may be used with Haemonetics
apheresis devices. See the Haemonetics Operation Manual for full operating
instructions.Prior to use of the solutions, check the solutions for leaks by squeezing each of the
bags firmly. If leaks are found, discard the solution. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEUKOTRAP WB SYSTEM
leukotrap wb system kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-262 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53157-262-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 BAG 1 mL in 63 Part 2 0 BAG 1 mL in 100 Part 1 of 2 ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE
anticoagulant citrate phosphate double dextrose injection, solutionProduct Information Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE - UNII:IY9XDZ35W2) DEXTROSE 3.21 g in 63 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.206 g in 63 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) 1.66 g in 63 mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) 0.14 g in 63 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 63 mL in 1 BAG; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN820915 Part 2 of 2 ADDITIVE SOLUTION - 3
additive solution - 3 injection, solutionProduct Information Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161) ADENINE 0.03 g in 100 mL DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE, UNSPECIFIED FORM - UNII:IY9XDZ35W2) DEXTROSE 1.1 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) 0.276 g in 100 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.588 g in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.41 g in 100 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.042 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 100 mL in 1 BAG; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN820915 09/23/1983 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN820915 09/22/1983 Labeler - Haemonetics Corporation (057827420) Establishment Name Address ID/FEI Business Operations Haemonetics Manufacturing Inc 078598396 manufacture(53157-262)
