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.
Leukotrap Wb System - Cp2d Solution
FDA Label NDC 87069-726
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gvs Tm Inc for the product Leukotrap Wb System - Cp2d (NDC 87069-726). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding intended use of the device, description, how supplied, storage and handling, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter (WBF2) and Sampling System
How Supplied
Sterile, nonpyrogenic fluid path. Sterilized by steam.
Storage And Handling
If moisture is observed on the outside of the collection system when removed from the cellophane pouch, subsequent handling and storage of an unused set within the foil pouch could encourage the growth of mold on the base label. Do not remove bag(s) from the foil pouch until ready to use. Unused bags in opened foil pouches may be kept 30 days by folding and SECURING open end of pouch
to prevent possible loss of moisture. Store at room temperature. Avoid excessive heat, protect from freezing.
* Please review the disclaimer below.
