Intended Use Of The Device
Intended for use only with automated red cell apheresis devices
to collect red blood cells and plasma (FFP and PF24).
Cp2d Solution
FDA Label NDC 87069-455
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 Cp2d (NDC 87069-455). 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, storage and handling section, warnings and precautions, description section, statement of identity, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Storage And Handling Section
Store at room temperature (25 °C/77 °F). Avoid excessive heat.
Protect from freezing.
Warnings And Precautions
Warnings
Not for direct intravenous infusion.
Single-use container – discard unused portion. (do not reuse)
Do not use unless the solution is clear and no leaks are detected.
Precautions
Use only with automated red-cell apheresis devices and follow the Operator’s Manual.
Refer to the package insert for complete instructions.
Storage/handling: Store at 25 °C/77 °F, avoid excessive heat, protect from freezing.
Pouch is a moisture barrier; handle to maintain package integrity.
Description Section
ANTICOAGULANT CITRATE PHOSPHATE DOUBLE
DEXTROSE SOLUTION (CP2D), 250 mL
0455A-00
Statement Of Identity
ANTICOAGULANT CITRATE PHOSPHATE DOUBLE
DEXTROSE SOLUTION (CP2D), 250 mL
0455A-00
Package Label
Manufacturer information: GVS TM Inc.
1630 W Industrial Park St
Covina, CA 91722, USA
ANTICOAGULANT CITRATE PHOSPHATE DOUBLE
DEXTROSE SOLUTION (CP2D), 250 mL
Intended for use only with automated red cell apheresis devices
to collect red blood cells and plasma (FFP and PF24). See the
appropriate Operator’s Manual for additional information and
complete usage instructions.
Each 100 mL contains:
Citric Acid (Monohydrate), USP 0.327 g
Sodium Citrate (Dihydrate), USP 2.630 g
Monobasic Sodium Phosphate (Monohydrate), USP 0.222 g
Dextrose (Anhydrous), USP 4.640 g
CAUTION: Refer to package insert. Not for direct intravenous
infusion. The pouch is a moisture barrier.
Do not use unless solution is clear and no leaks detected.
Single use container. Discard unused portion.
Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only.
Store at room temperature (25 °C/77 °F). Avoid excessive heat.
Protect from freezing.
REF: 0455A-00
lot and expiry date
126616-00 REV.0 - template number
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