Intended Use Of The Device
For collections of 500 ml of whole blood
Blood Collection System Solution
FDA Label NDC 87069-121
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 Blood Collection System (NDC 87069-121). 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
Blood Collection System with Nutricel Additive Solution. CPD2/AS-3 Triple with Sampling System
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 open pouches can may be kept up to 30 days by folding and securing open end of pouch to prevent possible loss of moisture.
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