FDA.reportPublic FDA data

CP2D/AS-3 - 123-63

Manufacturer
GVS TM INC
Effective date
2026-06-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-18 02:08:31

Label at a glance#

ProductLeukotrap RC PL System
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#

DESCRIPTION SECTION

Leukotrap RC PL system

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 and platelets with pre-storage leukocyte reduction

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

IFU 4IFU 4IFU 3IFU 3IFU 2IFU 2IFU 1IFU 1case labelcase labelPouch labelPouch labelBag labelBag labelBag labelBag labelBag labelBag label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)20810197810986(17)000000(10)0000000GTIN-14: 20810197810986
GTIN storage (14 digits): 20810197810986		leukotrap 11.jpg
BarcodeData Matrix(01)20387069123630(17)000000(10)0000000GTIN-14: 20387069123630
GTIN storage (14 digits): 20387069123630		leukotrap 11.jpg
Data codeCode 128=)1GV0012363whole blood volunteer donor.jpg
Data codeCode 128=)5GV0012363red blood cells.jpg
Data codeCode 128=)6GV0012363platelets or plasma volunteer donor.jpg

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87069-12387069-123-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eab581-bc48-f9f0-e063-6394a90a4b932026-06-25Exact identifier
ndc (product): 87069-123
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54e9a497-7a94-44c9-e063-6294a90a84da2026-06-23Exact identifier
ndc (package): 87069-123-63
ndc (product): 87069-123
ndc11 (package): 87069012363
spl id: 54e9a497-7a95-44c9-e063-6294a90a84da
spl set id: 54e9a497-7a94-44c9-e063-6294a90a84da
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb0462-cd00-4467-e063-6394a90aa3712026-06-23Exact identifier
ndc (product): 87069-123

Reported adverse events (FAERS/openFDA)#

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