FDA.reportPublic FDA data

CPDA-1 - 136-62

Manufacturer
GVS TM INC
Effective date
2026-06-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-18 02:10:18

Label at a glance#

ProductLeukotrap WB System
Active ingredientDEXTROSE MONOHYDRATE, SODIUM CITRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ADENINE, CITRIC ACID MONOHYDRATE
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#

INTENDED USE OF THE DEVICE

Intended for the collection of whole blood and preparation of red blood cells and plasma with pre-storage
leukocyte reduction.

DESCRIPTION SECTION

CPDA-1 Blood Bag Unit with In-Line WBF Filter (WBF2) and Sampling System

HOW SUPPLIED SECTION

Sterile, nonpyrogenic fluid path. Sterilized by steam.

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 labelBag labelBag 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)20810197810818(17)000000(10)0000000GTIN-14: 20810197810818
GTIN storage (14 digits): 20810197810818		Case label 1.jpg
BarcodeData Matrix(01)20387069136623(17)000000(10)0000000GTIN-14: 20387069136623
GTIN storage (14 digits): 20387069136623		Case label 1.jpg
Data codeCode 128=)1GV0013662whole blood 10.jpg
Data codeCode 128=)2GV0013662red blood cells 8.jpg
Data codeCode 128=)3GV0013662plasma 4.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87069-13687069-136-62

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
DEXTROSE MONOHYDRATELX22YL083GACTIB
SODIUM CITRATE1Q73Q2JULRACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNACTIB
ADENINEJAC85A2161ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM

Source Document#

Source XML

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 SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
ndc (package): 87069-136-62
ndc (product): 87069-136
ndc11 (package): 87069013662
spl id: 54fd8a72-0528-df0c-e063-6294a90abe75
spl set id: 54fd8a72-0527-df0c-e063-6294a90abe75
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
ndc (product): 87069-136

Reported adverse events (FAERS/openFDA)#

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