Anticoagulant Citrate Phosphate Dextrose (cpd) Blood-pack Units In Pl 146 Plastic Solution
FDA Label NDC 0942-9201

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fenwal, Inc. for the product Anticoagulant Citrate Phosphate Dextrose (cpd) Blood-pack Units In Pl 146 Plastic (NDC 0942-9201). 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 instructions for blood collection using anticoagulant citrate phosphate dextrose solution, usp (cpd) single and multiple blood-pack® units, package/label display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Instructions For Blood Collection Using Anticoagulant Citrate Phosphate Dextrose Solution, Usp (Cpd) Single And Multiple Blood-Pack® Units

Rx only

Integral Donor Tube (IDT)
Use aseptic technique.

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:
    • (a)Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.
    • (b)Remove needle cover, being careful not to drag the cover across the needle point.

      • Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.

      • 7.Mix blood and anticoagulant at several intervals during collection and immediately after collection.
      • 8.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%.
      • 9.Apply hemostat to donor tubing.
      • 10.Release pressure on the donor’s arm as appropriate and withdraw donor needle.

        • Precaution: Use care to avoid accidental needle sticks when filling sample tubes. The Fenwal Needle/Tube Sampling Protector may be used to reduce the risk of needle stick injury.

        • 11.Slide sample tube onto needle until stopper is punctured. Release hemostat to fill sample tube.
        • 12.To fill additional tubes, apply a hemostat to donor tube and repeat step 11.
        • 13.Strip blood from donor tubing into 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.
        • 14.Discard needle into an appropriate biohazardous waste container following established procedures.
        • 15.Store suspended CPD Whole Blood/Red Blood Cells between 1 and 6° C.
        • 16.Infuse CPD Whole Blood/Red Blood Cells within 21 days of collection.

          • Dispose of container appropriately. Single use only.

          Store at Controlled Room Temperature.
          USP Definition of “Controlled Room Temperature”
          United States Pharmacopeia, General Notices
          United States Pharmacopeial Convention, Inc.
          12601 Twinbrook Parkway, Rockville, MD.

          Fenwal, Inc.
          Lake Zurich, IL 60047 USA

          1-800-933-6925

          Made in USA

          Fenwal International, Inc.
          Road 357, Km. 0.8
          Maricao, PR 00606

          – Manufacturer

          FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc

          © 2008 Fenwal, Inc. All rights reserved.

          07-19-58-106 REV: B
          10/2008

Package/Label Display Panel

Code 4R0837MC

1 Unit

Fenwal™

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ Unit

Single For Collection and Processing of 250 mL Blood
Integral Donor Tube, 16 ga. Ultra Thin Wall Needle

Rx only

Each unit consists of a PL 146 Plastic primary container with 35 mL of CPD solution containing 921 mg Sodium Citrate (dihydrate) USP, 893 mg Dextrose (monohydrate) USP, 105 mg Citric Acid (anhydrous) USP and 78 mg Monobasic Sodium Phosphate (monohydrate) USP. pH may have been adjusted with sodium hydroxide.

Sterile, non-pyrogenic fluid path.
See instructions for use.

Single use only.
Dispose of container appropriately.

FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.

Store at Controlled Room Temperature (refer to direction insert).

  • Open pouch by tearing across at notch.
  • Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.
  • 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, provided:
    • I)Units are not removed from foil pouch, or
    • II)Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once.
      • Units removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within 4 days (96 hours). Units out of the foil pouch for longer than 96 hours must be discarded.

        • Manufacturer:
        Fenwal, Inc.
        Lake Zurich, IL 60047 USA

        Made in USA

        07-28-05-458 REV: A

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