PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL DISPLAY PANEL. Code 4R0837MC1 Unit Fresenius KabiFenwal Blood-Pack Unit SingleAnticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) For Collection of 250 mL Blood Integral Donor Tube, 16 ga. Ultra Thin Wall Fenwal HighFlo NeedleRx onlyEach unit consists of 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, 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 OnlyStore at Controlled Room Temperature (refer to direction insert). Protect from freezing. Avoid excessive heat.oOpen pouch by tearing across at notch.oDirect handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.oUnused 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, orII)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.oUnits removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within days (96 hours). Units out of the foil pouch for longer than 96 hours must be discarded.Manufacturer Fresenius Kabi AG 61346 Bad Homburg Germany www.fresenius-kabi.com Made in US 47-28-12-755 REV: . oOpen pouch by tearing across at notch.. oDirect handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.. oUnused 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.. oUnits removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within days (96 hours). Units out of the foil pouch for longer than 96 hours must be discarded.. 4r0837mc-primlbl.

SPL UNCLASSIFIED SECTION.

4R0012MC, 4R0837MC, 4R0112MC Fenwal Blood-Pack Units Rx only With Integral Donor Tube Using ACD or CPD and Fenwal HighFlo Needle Instructions for Use Collection Procedure: Use aseptic technique. Precaution: Do not use unless solution 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 from donor scale as far as possible below donor arm and clamp donor tubing. 4. Following blood center procedures, apply pressure to donors arm and disinfect site of venipuncture. 5. Remove HighFlo1 needle cover per instructions below: a) Holding the hub and cover near the tamper-evident seal, twist cover and hub in opposite directions to break seal. b) Remove needle cover, being careful not to drag the cover across the needle point. Following blood center procedures, perform venipuncture, appropriately secure donor needle and/or tubing and release clamp. 6. Mix blood and anticoagulant at several intervals during collection and immediately after collection. 7. 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%. 8. Apply clamp to donor tube. 9. As appropriate, release pressure on the donors arm, collect donor samples following established procedures and withdraw donor needle. 10. Withdrawal of needle into needle guard. Precaution: The needle guard must be held stationary while the needle is withdrawn into it. a) Hold sides of needle guard near the front, between the index finger and thumb. Pull the hub back smoothly until the needle is completely enclosed and securely locked into the needle guard. b) Confirm the needle is completely enclosed and securely locked into the needle guard. 11. Strip blood from donor tubing into container, mix and allow the tubing to refill; repeat once. Seal at marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching. 12. Discard needle in needle guard into an appropriate biohazardous waste container following established procedures. 13. Store filled unit between and C. 14. Infuse blood within 21 days of collection. Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Definition of Controlled Room Temperature: A temperature maintained thermostatically that encompasses the usual and customary working environment of 20 to 25C (68 to 77F); that results in mean kinetic temperature calculated to be not more than 25C; and that allows for excursions between 15C and 30C (59 and 86F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40C are permitted as long as they do not exceed 24 hours ... The mean kinetic temperature is calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations. Reference: United States Pharmacopeia, General Notices. United States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville, MD. Symbols with Definitions Van der Meer, P.F., de Korte, D. Increase of blood donation speed by optimizing the needle-to-tubing connection: an application of donation software. Vox Sanguinis 2009, 97: 21-25Manufacturer Fresenius Kabi AG 61346 Bad Homburg Germany www.fresenius-kabi.com 1-800-933-6925 (C) 2019 Fresenius Kabi AG. All rights reserved. 47-23-13-621 REV: A. 4R001mc-symbols. 4R0837mcmfglbl.