Label: STERILE CORD BLOOD COLLECTION UNIT- cord blood collection unit solution
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Contains inactivated NDC Code(s)
NDC Code(s): 62646-791-08 - Packager: Medsep Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 9, 2011
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- Official Label (Printer Friendly)
- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD)
- INDICATIONS AND USAGE
- WARNINGS
- GENERAL PRECAUTIONS
- HOW SUPPLIED
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INFORMATION FOR PATIENTS
Medsep Corporation, A Subsidiary of Pall Corp., Covina, CA 91722, USA
Visit us at www.pall.com/medical
For Pall customer service, call: 1.800.645.6578
DonorCare is a registered trademark of ITL Corporation, Canberra, Australia. Produced under license from ThermoGenesis Corp.
Instructions for Use
1. Ensure DonorCare® Needle Guard (DCNG) is positioned on the tubing between the needle hub and Pinch Clamp. Engage Pinch Clamp. Ensure tethered cap is placed securely on the air vent.
2. Using aseptic technique, insert needle into umbilical vein, disengage Pinch Clamp to collect cord blood, mixing frequently, according to standard procedures.
3. Upon completion of collection, engage Pinch Clamp then withdraw needle from umbilical vein. Slide the DCNG midway over the needle hub. While holding the sides of DCNG near front, grasp tubing and pull smoothly, pulling needle into the DCNG until it locks into place. Confirm that needle is locked by listening for the second click as the needle is drawn into the DCNG. Ensure that tubing cannot be pulled through DCNG.
4. Place the bag on a work surface. While holding the tubing above the bag, open the tethered cap on the air vent. Allow the blood to drain from the tubing into the bag.
5. When the tubing has been drained, hold tubing vertical and seal tubing directly below the Y-piece with air vent.
6. Detach and discard needle, DCNG, Pinch Clamp, Air Vent and tubing according to standard procedures.
7. Determine amount of anticoagulated blood collected. If required, add sedimenting agent to CPD anticoagulated blood through Sample Port using a syringe according to standard procedures.
8. Mix well. Take care to strip and mix any blood in tubing.
9. Load bag into centrifuge cup. It is suggested that a means of support is used to prevent bag from collapsing and to reduce wrinkles.
10. Centrifuge according to standard procedures to obtain mononuclear cell-rich plasma.
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BAG LABEL
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION
35 ml Anticoagulant Citrate Phosphate Dextrose Solution for collection of up to 210 ml of umbilical cord blood. Each 35 ml of CPD solution contains 0.921 g sodium citrate (dihydrate), USP; 0.893 g dextrose (monohydrate), USP; 0.114 g citric acid (monohydrate), USP; and 0.078 g monobasic sodium phosphate (monohydrate), USP. Use only if solution is clear.
Warning: This product may transmit infectious agents. Sterile, nonpyrogenic fluid path. Do not irradiate. Rx only.
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INGREDIENTS AND APPEARANCE
STERILE CORD BLOOD COLLECTION UNIT
cord blood collection unit solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62646-791 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) (CITRIC ACID - UNII:2968PHW8QP) SODIUM CITRATE 0.921 g in 35 mL DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (DEXTROSE - UNII:IY9XDZ35W2) DEXTROSE MONOHYDRATE 0.893 g in 35 mL CITRIC ACID (UNII: 2968PHW8QP) (CITRIC ACID - UNII:2968PHW8QP) CITRIC ACID 0.114 g in 35 mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHORIC ACID - UNII:E4GA8884NN) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.078 g in 35 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62646-791-08 35 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA800222 03/16/2011 Labeler - Medsep Corporation (928224765) Registrant - Medsep Corporation (928224765) Establishment Name Address ID/FEI Business Operations Medsep Corporation 928224765 manufacture, relabel, repack