Leukotrap WB System

LEUKOTRAP WB SYSTEM-
Haemonetics Corporation

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.

Envelope Label
(click image for full-size original)

LEUKOTRAP WB SYSTEM
leukotrap wb system kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-262
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53157-262-01 1 KIT in 1 KIT None
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, solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE (DEXTROSE) DEXTROSE 3.21 g in 63 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 0.206 g in 63 mL
SODIUM CITRATE 1.66 g in 63 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.14 g in 63 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 63 mL in 1 BAG None
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, solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADENINE (ADENINE) ADENINE 0.03 g in 100 mL
DEXTROSE (DEXTROSE, UNSPECIFIED FORM) DEXTROSE 1.1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.276 g in 100 mL
SODIUM CITRATE 0.588 g in 100 mL
SODIUM CHLORIDE 0.41 g in 100 mL
CITRIC ACID MONOHYDRATE 0.042 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 100 mL in 1 BAG None
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 Operations
Haemonetics Manufacturing Inc 078598396 manufacture (53157-262)

Revised: 01/2022 Haemonetics Corporation

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