How Supplied
Sterile, non-pyrogenic fluid path, sterilized by steam
Leukotrap Wb System - Cp2d Solution
FDA Label NDC 87069-126
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 87069-126). 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 how supplied, intended use of the device, description, 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
Intended Use Of The Device
For collection of 500 ml of whole blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction
Description
Leukotrap WB system
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.
Package Label.Principal Display Panel
Bag Label 3 (Plasma)
* Please review the disclaimer below.
