FDA.reportPublic FDA data

Leukotrap WB System

Manufacturer
Haemonetics Corporation | Haemonetics Manufacturing Inc
Effective date
2022-01-26
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:40:09

Label at a glance#

ProductLeukotrap WB System
Active ingredientDEXTROSE, ADENINE
Label structure2 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

CP2D Anticoagulant Solution and AS-3 Solution may be used with Haemonetics

apheresis devices. See the Haemonetics Operation Manual for full operating

instructions.

Prior to use of the solutions, check the solutions for leaks by squeezing each of the

bags firmly. If leaks are found, discard the solution.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Envelope LabelEnvelope Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53157-262-012025-01-30C16284748780-12cef2736-8841-d83d-e063-dadaa90ab31fLeukotrap WB Sytem

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53157-262-01Leukotrap WB System1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53157-262LEUKOTRAP WB SYSTEM KIT [HAEMONETICS CORPORATION]1Legacy NDC, 1 package rows20220218_d67faebb-c272-36f0-e053-2a95a90a7ae8.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53157-26253157-262-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEXTROSEIY9XDZ35W2ACTIB
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
ADENINEJAC85A2161ACTIB
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEXTROSEIY9XDZ35W2ACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d67faebb-c273-36f0-e053-2a95a90a7ae8d67faebb-c272-36f0-e053-2a95a90a7ae82022-01-26Exact identifier
spl id: d67faebb-c273-36f0-e053-2a95a90a7ae8
spl set id: d67faebb-c272-36f0-e053-2a95a90a7ae8

Reported adverse events (FAERS/openFDA)#

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