Cp2d Listing

Cp2d Listing
SPL v2
SPL
SPL Set ID 3fa2e438-2ff0-a2df-e063-6394a90ac7b5
Route
INTRAVENOUS
Published
Effective Date 2025-09-30
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Dextrose (4.64 g)
Inactive Ingredients
Citric Acid Monohydrate Sodium Citrate Monobasic Potassium Phosphate

Identifiers & Packaging

Marketing Status
NDA Active Since 2025-09-30

Description

Intended for use only with automated red cell apheresis devices to collect red blood cells and plasma (FFP and PF24).

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.

Storage and Handling

Store at room temperature (25 °C/77 °F). Avoid excessive heat. Protect from freezing.


Medication Information

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.

Storage and Handling

Store at room temperature (25 °C/77 °F). Avoid excessive heat. Protect from freezing.

Description

Intended for use only with automated red cell apheresis devices to collect red blood cells and plasma (FFP and PF24).

Section 60560-0

Intended for use only with automated red cell apheresis devices

to collect red blood cells and plasma (FFP and PF24).

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

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

Storage and Handling Section

Store at room temperature (25 °C/77 °F). Avoid excessive heat.

Protect from freezing.


Structured Label Content

Section 60560-0 (60560-0)

Intended for use only with automated red cell apheresis devices

to collect red blood cells and plasma (FFP and PF24).

Package Label (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

Description Section (Description section)

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE

DEXTROSE SOLUTION (CP2D), 250 mL

0455A-00

Statement of Identity (Statement of identity)

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE

DEXTROSE SOLUTION (CP2D), 250 mL

0455A-00

Warnings and Precautions (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.

Storage and Handling Section (Storage and handling section)

Store at room temperature (25 °C/77 °F). Avoid excessive heat.

Protect from freezing.


Advanced Ingredient Data


Raw Label Data

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