FDA.reportPublic FDA data

CP2D/AS-3 - 129-64

Manufacturer
GVS TM INC
Effective date
2026-06-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-08 02:04:09

Label at a glance#

ProductLeukotrap RC 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 System

HOW SUPPLIED SECTION

Sterile, non-pyrogenic 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.

INTENDED USE OF THE DEVICE

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

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)20810197810726(17)000000(10)0000000GTIN-14: 20810197810726
GTIN storage (14 digits): 20810197810726		leukotrap 18.jpg
BarcodeData Matrix(01)20387069129649(17)000000(10)0000000GTIN-14: 20387069129649
GTIN storage (14 digits): 20387069129649		leukotrap 18.jpg
Data codeCode 128=)1GV0012964whole blood 8.jpg
Data codeCode 128=)5GV0012964red blood cells 6.jpg
Data codeCode 128=)6GV0012964platelets or plasma 3.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
87069-12987069-129-64

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 SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC4c0dec79-1648-1cfd-e063-6394a90a88cc2026-07-03Exact identifier
ndc (product): 87069-129
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb3c81-5cc8-03c4-e063-6294a90a20652026-06-23Exact identifier
ndc (product): 87069-129
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54ebb700-3bcf-d0e3-e063-6394a90a57c82026-06-23Exact identifier
ndc (package): 87069-129-64
ndc (product): 87069-129
ndc11 (package): 87069012964
spl id: 54ebb700-3bd0-d0e3-e063-6394a90a57c8
spl set id: 54ebb700-3bcf-d0e3-e063-6394a90a57c8

Reported adverse events (FAERS/openFDA)#

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