Label: ACD BLOOD-PACK UNITS (PL 146 PLASTIC)- anticoagulant citrate dextrose (acd) solution
- NDC Code(s): 0942-9001-01
- Packager: Fenwal, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated November 30, 2012
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- Instructions for Blood Collection Using CPD or ACD Single Blood-Pack™ Units
Integral Donor Tube (IDT)
Use aseptic technique.
Precaution: Do not use unless solution is clear.
- 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.
- Adjust donor scale to desired collection weight.
- Position primary container from donor scale as far as possible below donor arm and clamp donor tubing with hemostat.
- Apply pressure to donor’s arm and disinfect site of venipuncture.
- If blood pressure cuff is used, inflate to approximately 60 mmHg.
Remove needle cover per instructions below:
- Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.
- 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.
- Mix blood and anticoagulant at several intervals during collection and immediately after collection.
- 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%.
- Apply hemostat to donor tube.
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.
- 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.
- Discard needle into an appropriate biohazardous waste container following established procedures.
- Store filled unit between 1 and 6° C.
- Infuse blood within 21 days of collection.
Store at Controlled Room Temperature.
USP Definition of “Controlled Room Temperature”
United States Pharmacopeia, General Notices.
United States Phramacopeial Convention, Inc.
12601 Twinbrook Parkway, Rockville, MD
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- PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Anticoagulant Citrate Dextrose Solution, USP (ACD) Formula A BLOOD-PACK™ Unit
Single For Collection of 450 mL Blood
Integral Donor Tube, 16 ga. Ultra Thin Wall Needle
Each unit consists of a PL 146 Plastic primary container with 67.5 mL of ACD solution containing 1.65 g Dextrose (monohydrate) USP, 1.48 g Sodium Citrate (dihydrate) USP and 493 mg Citric Acid (anhydrous) USP.
Sterile, non-pyrogenic fluid path
See instructions for use.
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:
l) Units are not removed from foil pouch, or
ll) 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.
FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.
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- INGREDIENTS AND APPEARANCE
ACD BLOOD-PACK UNITS (PL 146 PLASTIC)
anticoagulant citrate dextrose (acd) solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0942-9001 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 1.65 g in 67.5 mL TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) TRISODIUM CITRATE DIHYDRATE 1.48 g in 67.5 mL ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 493 mg in 67.5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0942-9001-01 67.5 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN160918 03/01/2007 Labeler - Fenwal, Inc. (794519020) Establishment Name Address ID/FEI Business Operations Fenwal International 091164590 MANUFACTURE(0942-9001)