FDA Label for Cp2d
View Indications, Usage & Precautions
Cp2d Product Label
The following document was submitted to the FDA by the labeler of this product Gvs Tm Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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).
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
* Please review the disclaimer below.
