CP2D by GVS TM INC CP2D solution

CP2D by

Drug Labeling and Warnings

CP2D by is a Prescription medication manufactured, distributed, or labeled by GVS TM INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CP2D 
cp2d solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 87069-455
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE, UNSPECIFIED FORM	4.64 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87069-455-42	24 in 1 CARTON
1	NDC: 87069-455-02	250 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN820915	09/30/2025

Labeler - GVS TM INC (119067149)

Registrant - GVS TM INC (119067149)

Establishment
Name	Address	ID/FEI	Business Operations
GVS TM INC		119067149	manufacture(87069-455)