FDA.reportPublic FDA data

CP2D/AS-3 - 126-62

Manufacturer
GVS TM INC
Effective date
2026-07-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-08 02:03:40

Label at a glance#

ProductLeukotrap WB System - CP2D
Active ingredientDEXTROSE, UNSPECIFIED FORM
Label structure5 sections

Storage and handling

Store at room temperature, avoid excessive heat, protect from freezing. Unused bags in opened pouch may be kept up to 30 days by folding and securing open end of pouch to prevent possible loss of moisture.

Label contents#

Full prescribing information#

HOW SUPPLIED SECTION

Sterile, non-pyrogenic fluid path, sterilized by steam

INTENDED USE OF THE DEVICE

For collection of 500 ml of whole blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction

DESCRIPTION SECTION

Leukotrap WB system

STORAGE AND HANDLING SECTION

Store at room temperature, avoid excessive heat, protect from freezing. Unused bags in opened pouch may be kept up to 30 days by folding and securing open end of pouch to prevent possible loss of moisture.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bag label 1Bag label 1Bag label 2Bag label 2Bag Label 3Bag Label 3Pouch labelPouch labelCase labelCase labelIFU 1IFU 1IFU 2IFU 2IFU 3IFU 3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)20810197810702(17)000000(10)0000000GTIN-14: 20810197810702
GTIN storage (14 digits): 20810197810702		leukotrap 8.jpg
BarcodeData Matrix(01)20387069126624(17)000000(10)0000000GTIN-14: 20387069126624
GTIN storage (14 digits): 20387069126624		leukotrap 8.jpg
Data codeCode 1281GV0012662whole blood 4.jpg
Data codeCode 128=)2GV0012662red blood cells 3.jpg
Data codeCode 128=)3GV0012662plasma.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87069-12687069-126-62

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2ACTIB
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-11-28monthly-update2026-07-17 21:40:11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leukotrap WB System - CP2DCP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a82ea8-69bf-f061-e063-6394a90af3da2026-07-03Exact identifier
ndc (product): 87069-126
Leukotrap WB System - CP2DCP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a7d200-13cb-c0b0-e063-6294a90aafad2026-07-03Exact identifier
ndc (package): 87069-126-62
ndc (product): 87069-126
ndc11 (package): 87069012662
spl id: 55b57c0b-29e4-6d0f-e063-6394a90a9c34
spl set id: 44a7d200-13cb-c0b0-e063-6294a90aafad

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.