Description
Leukotrap RC PL System
Leukotrap Rc Pl System Solution
FDA Label NDC 87069-123
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 Rc Pl System (NDC 87069-123). 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 description, how supplied, storage and handling, intended use of the device, 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
How Supplied
Sterile, non-pyrogenic fluid path, sterilized by steam
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.
Intended Use Of The Device
For collection of 500 ml of whole blood and preparation of red blood cells, plasma and platelets with pre-storage leukocyte reduction
* Please review the disclaimer below.
