LEUKOTRAP RC SYSTEM- cp2d/as-3 triple blood bag unit with in-line rc2d filter and sampling system solution

Leukotrap RC System by

Drug Labeling and Warnings

Leukotrap RC System by is a Prescription medication manufactured, distributed, or labeled by GVS TM INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INTENDED USE OF THE DEVICE

For collection of 500ml of whole blood and preapration of red blood cells and plasma or red blood cells, plasma and platelets with pre-storage leukocyte reduction of red blood cells.

DESCRIPTION

Leukotrap RC System CP2D/AS-3 - Triple blood bag unit with In-Line RC2D filter and sampling system

HOW SUPPLIED

Sterile, Non-pyrogenic fluid pathway. Sterilized by Steam

STORAGE AND HANDLING

Store at room temperature. Unused bags in opened pouches may be kept 30 days by folding and securing open end of pouch to prevent possible loss of moisture.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEUKOTRAP RC SYSTEM 
cp2d/as-3 triple blood bag unit with in-line rc2d filter and sampling system solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 87069-129
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE, UNSPECIFIED FORM	3.57 g  in 70 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87069-129-63	18 in 1 CARTON
1		3 in 1 POUCH
1		70 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN820915	03/02/2026

Labeler - GVS TM INC (119067149)

Registrant - GVS TM INC (119067149)

Establishment
Name	Address	ID/FEI	Business Operations
GVS TM INC		119067149	manufacture(87069-129)