CPDA-1

Manufacturer
Fenwal, Inc. | Fenwal International, Inc.
Effective date
2019-11-26
Label type
Human Prescription Drug Label
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:56:50

Label at a glance#

ProductCPDA-1
Active ingredientDextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, Sodium Phosphate, Monobasic, Monohydrate, Adenine
Label structure2 sections

Label contents#

Full prescribing information#

Instructions for Blood Collection Using Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Units

SPL UNCLASSIFIED SECTION

Integral Donor Tube (IDT)

Use aseptic technique.

This product has components which contain natural rubber latex.

Precaution: Do not use unless anticoagulant is clear.

  1. Identify Blood-Pack unit using appropriate donor identification system. Confirm that all numbered tubing of each Blood-Pack unit contains its own identical segment numbers.
  2. Adjust donor scale to desired collection weight.
  3. Position primary container on the donor scale as far as possible below donor arm and clamp donor tubing with hemostat.
  4. Apply pressure to donor’s arm and disinfect site of venipuncture.
  5. If blood pressure cuff is used, inflate to approximately 60 mmHg.
  6. Remove needle cover per instructions below:
    1. Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.
    2. Remove needle cover, being careful not to drag the cover across the needle point.
  7. Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.
  8. Mix blood and anticoagulant at several intervals during collection and immediately after collection.
  9. Collect the appropriate volume based on Blood-Pack unit used. Note: The volume of anticoagulant is sufficient for the blood collection indicated on Blood-Pack unit ± 10%.
  10. Apply hemostat to donor tubing.
  11. As appropriate, release pressure on the donor’s arm, collect donor samples following established procedures and withdraw donor needle.

Precaution: Use care to avoid accidental needle sticks. One of the Fenwal Needle Protector Systems may be used to reduce the risk of needle stick injury.

  1. Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once. Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.
  2. Discard needle into an appropriate biohazardous waste container following established procedures.
  3. Store suspended CPDA-1 Whole Blood/ Red Blood Cells between 1 and 6° C.
  4. Infuse CPDA-1 Whole Blood/Red Blood Cells within 35 days of collection.

For further processing with multiple Blood-Pack units, use standard component processing techniques.

Baxter Healthcare Corporation
Fenwal Division
Deerfield, IL 60015 USA

Made in USA

07-19-29-257
Iss. May 2002

Baxter, Fenwal and Blood-Pack are trademarks of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

PACKAGE/LABEL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Code 4R6312

20 Units

Baxter

Fenwal

Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Unit

Triple For the Collection and Processing of 450 mL Blood

Integral Donor Tube, 16 ga. Ultra Thin Wall Needle

Each unit consists of a PL 146 Plastic primary container with 63 mL of CPDA-1 solution containing 2 g Dextrose (monohydrate) USP, 1.66 g Sodium Citrate (dihydrate) USP, 188 mg Citric Acid (anhydrous) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP and 17.3 mg Adenine USP, pH may have been adjusted with sodium hydroxide; two empty 400 mL PL 1240 plastic Transfer Pack Containers.

Rx only

Sterile, nonpyrogenic fluid path
See instructions for use.

Store at room temperature.

  • Open pouch by tearing across at notch.
  • Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture.
  • Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.
  • Units removed from the foil pouch must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded.

U.S. Pat. Nos. 4,402,682; 4,413,992; 4,505,708; 4,508,534; 4,574,456; 5,314,421; 5,507,525.

Baxter, Fenwal, Blood-Pack, PL 146 and Transfer Pack are trademarks of Baxter International Inc.; Baxter, Fenwal and Blood-Pack are registered in the U.S. Patent and Trademark Office.

Baxter Healthcare Corporation
Fenwal Division
Deerfield, IL 60015 USA

Made in USA

07-28-35-996
02/2003

Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Unit label
Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Unit label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AdenineACTIVE INGREDIENTJAC85A21613
Anhydrous Citric AcidACTIVE INGREDIENTXF417D3PSL3
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083G3
Sodium Phosphate, Monobasic, MonohydrateACTIVE INGREDIENT593YOG76RN3
Trisodium Citrate DihydrateACTIVE INGREDIENTB22547B95K3
AdenineACTIVE MOIETYJAC85A21613
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSL3
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OK3
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR3

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0942-93040942-9304-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c635a6f6-c26a-4844-a688-2f92f46adae5425e4668-de6d-4e92-b240-a30dee7252232021-09-21Exact identifier
spl set id: 425e4668-de6d-4e92-b240-a30dee725223

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.