Intended Use Of The Device
For collection of 500ml of whole blood and preapration of red blood cells and plasma or red blood cells, plasma and platelets with pre-storage leukocyte reduction of red blood cells.
Leukotrap Rc System Solution
FDA Label NDC 87069-129
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 System (NDC 87069-129). 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
Leukotrap RC System CP2D/AS-3 - Triple blood bag unit with In-Line RC2D filter and sampling system
How Supplied
Sterile, Non-pyrogenic fluid pathway. Sterilized by Steam
Storage And Handling
Store at room temperature. Unused bags in opened pouches may be kept 30 days by folding and securing open end of pouch to prevent possible loss of moisture.
Package Label.Principal Display Panel
Ifu (Ifu 14)
Ifu (Ifu 3)
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