DESCRIPTION SECTION.

MACO BIOTECH Collection Sterile Cord Blood Collection Unit (MSC127D). The MSC127D Sterile Cord Blood Collection Unit consists of 300 mL collection bag containing 27 mL of Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD), 40 mL rinsing bag containing mL of CPD and two 12 gauge needles with protective shield (SECUVAM) for the used needle.Sterile, non-pyrogenic fluid path. Sterilized by steam.Rx only.This product is not made with natural rubber latex.

HOW SUPPLIED SECTION.

HOW SUPPLIED. MSC127D Sterile Cord Blood Collection Unit contains:300 mL collection bag containing 27 mL CPD40 mL rinsing bag contaning mL CPD2-12 gauge needles with protective shield (SECUVAM) for used needleGraduation label as visual aid to approximate the volume. 300 mL collection bag containing 27 mL CPD. 40 mL rinsing bag contaning mL CPD. 2-12 gauge needles with protective shield (SECUVAM) for used needle. Graduation label as visual aid to approximate the volume.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. MSC127D For collection of up to 250 mL of umbilical cord blood. Use aseptic technique.

INSTRUCTIONS FOR USE SECTION.

INSTRUCTIONS FOR USE Carefully Read All the Instructions Before Use Representative Product DrawingI. PREPARATIONBefore use, verify the integrity of the collection unit (overwrap, outlet ports, tubing...).Only contents inside the inner wrap are sterile and acceptable for use in sterile field if pouch is unopened and undamaged.II. COLLECTION PROCEDUREClose all clamps 3A, 3B and 3C (clamp should remain open).After clamping and sectioning of the umbilical cord, place the collection bag on mixer and perform venipuncture at lower end of the umbilical cord with first needle 1A.Note: Umbilical venipunctures can be done before or after the expulsion of the placenta according to your local procedures.3. Open clamps 3A and 3C.4. Stimulate cord blood flow by massaging the cord from the top downward to increase volume of collection.5. When collection is completed, close clamps 3A and 3C.6. Remove needle 1A and slide down SECUVAM 2A (needle protector) over needle 1A.7. If necessary, perform second umbilical venipuncture on the upper part of the umbilical cord (near the mother).[See Warnings]: a. Open clamps 3B and 3C. b. Perform venipuncture on the umbilical cord using other needle 1B. c. When collection is completed, close clamps 3B and 3C. d. Remove needle 1B and slide down SECUVAM 2B (needle protector) over needle 1B. III. RINSING OF COLLECTIONLINEOpen clamp 3C.Snap the break-away cannula on top of rinsing bag 6.Roll up bag on itself to empty mL of anticoagulant (CPD) in the tubing to push the cord blood remaining in the tubing into the collection bag. Do not strip the tubing.Close clamp 3C.Proceed to section END OF COLLECTION if collection volume is less than 200 mL. For collection volumes greater than 200 mL, proceed to section IV ADDITION OF ANTICOAGULANT INTO THE COLLECTION BAG.IV. ADDITION OF ANTICOAGULANT INTO THE COLLECTION BAGUse this step only for collection volumes greater than 200 mL.Seal the tubing above the junction 5.Move clamp 3C near to junction 5.Using blood stripper, strip the tubing from junction towards the collection bag expelling the anticoagulant in the tubing into collection bag 8.Repeat this operation times.Mix collection bag 8.Close clamp 3C.Proceed to section END OF COLLECTION.V. END OF COLLECTIONClose clamp to secure th collection.Seal the tubing between clamp and collection bag 8.Fill in collection volume and CPD volume on the collection bag label. The amount of CPD is as follows: a. 27 mL if no additional CPD is added. b. 35 mL if additional mL CPD from rinsing bag is added to the collection bag as directed in section IV.4. For optimal cord blood quality, maintain the cord blood at an ambient temperature (18-26C 64.4-78.8F) or cold temperature (4-12C 39.2-53.6F).VI. CONTACT INFORMATIONManufactured for United States of America (U.S.A.) and Canada by Maco Productions Polonia, Sp. o.o.ul. Szwajcarska 22, 54-405 Wroclaw, POLAND+48 71 37 60 110For consumer information contact:For the U.S.A.: Distributed by Uneklo USA, Inc. dba Macopharma USA 3075 Breckinridge Boulevard, Suite 405, Duluth, GA 30096, USA (770) 270-6867For Canada: Distributed by Macopharma Canada 1200 McGill College, Suite 1715, Montreal (Quebec) H3B 4G7 (514) 866-2222VII. REFERENCESPope, B. Mitsakos, K., Bilgin, A., Hokin, B. and Grant, R.: Predicting overall viability of cord blood harvests. Transfusion 2012:52:1079-1085Salge-Bartels U. Huber. M, Kleiner K, Volkers P, Seitz R, Heiden M: Evaluation of Quality Parameters for Cord Blood Donations, Transfus Med Hemother 2009; 36:317-324Prof. Dr. Kogler, Jose Carreras CBB, medical center, University of Duesseldorf: General information on the institution and the production facility of the Jose Carreras Cord Blood Bank. 2014 Before use, verify the integrity of the collection unit (overwrap, outlet ports, tubing...).. Only contents inside the inner wrap are sterile and acceptable for use in sterile field if pouch is unopened and undamaged.. Close all clamps 3A, 3B and 3C (clamp should remain open).. After clamping and sectioning of the umbilical cord, place the collection bag on mixer and perform venipuncture at lower end of the umbilical cord with first needle 1A.. Open clamp 3C.. Snap the break-away cannula on top of rinsing bag 6.. Roll up bag on itself to empty mL of anticoagulant (CPD) in the tubing to push the cord blood remaining in the tubing into the collection bag. Do not strip the tubing.. Close clamp 3C.. Proceed to section END OF COLLECTION if collection volume is less than 200 mL. For collection volumes greater than 200 mL, proceed to section IV ADDITION OF ANTICOAGULANT INTO THE COLLECTION BAG.. Seal the tubing above the junction 5.. Move clamp 3C near to junction 5.. Using blood stripper, strip the tubing from junction towards the collection bag expelling the anticoagulant in the tubing into collection bag 8.. Repeat this operation times.. Mix collection bag 8.. Close clamp 3C.. Proceed to section END OF COLLECTION.. Close clamp to secure th collection.. Seal the tubing between clamp and collection bag 8.. Fill in collection volume and CPD volume on the collection bag label. The amount of CPD is as follows:. For the U.S.A.: Distributed by Uneklo USA, Inc. dba Macopharma USA. For Canada: Distributed by Macopharma Canada. Pope, B. Mitsakos, K., Bilgin, A., Hokin, B. and Grant, R.: Predicting overall viability of cord blood harvests. Transfusion 2012:52:1079-1085. Salge-Bartels U. Huber. M, Kleiner K, Volkers P, Seitz R, Heiden M: Evaluation of Quality Parameters for Cord Blood Donations, Transfus Med Hemother 2009; 36:317-324. Prof. Dr. Kogler, Jose Carreras CBB, medical center, University of Duesseldorf: General information on the institution and the production facility of the Jose Carreras Cord Blood Bank. 2014 RepresentativeProductDrawing.jpg.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

LABELS. Collection Bag LabelOverwrap LabelREF MSC127D. CollectionBagLabel. OverwrapLabel.

PRECAUTIONS SECTION.

PRECAUTIONS. DO NOT use if the overwraps or bags show any signs of alteration.This is single use sterile kit: under no circumstances should it be reused.For optimal cord blood quality it is recommended to maintain the cord blood at an ambient temperature (18-26C 64.4-78.8F) or cold temperature (4-12C 39.2-53.6F) and process within 48 hours of collection.1,2,3 If the collection volume is less than 60 mL, the cord blood should be processed withing 24 hours of collection.. DO NOT use if the overwraps or bags show any signs of alteration.. This is single use sterile kit: under no circumstances should it be reused.. For optimal cord blood quality it is recommended to maintain the cord blood at an ambient temperature (18-26C 64.4-78.8F) or cold temperature (4-12C 39.2-53.6F) and process within 48 hours of collection.1,2,3.

WARNINGS SECTION.

WARNINGS. Avoid contact with sharp objects.Do not irradiate collected cord blood or components.Making multiple punctures of the umbilical cord to increase collection volume may increase the risk of contamination.. Avoid contact with sharp objects.. Do not irradiate collected cord blood or components.. Making multiple punctures of the umbilical cord to increase collection volume may increase the risk of contamination.