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Sterile Cord Blood Collection Unit (MSC128D): Uses, Side Effects and Dosage

Status:
Prescription (Rx) Facts
Strength:
0.92 g/35 mL, 0.89 g/35 mL, 114.5 g/35 mL, 87.9 g/35 mL
Drug class:
Active ingredients:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Sterile Cord Blood Collection Unit (MSC128D)

INSTRUCTIONS FOR USE

Carefully Read All the Instructions Before Use

Representative Product Drawing

I. PREPARATION

1. Before use, verify the integrity of the collection unit (overwrap, outlet ports, tubing…).

  1. 2. Only contents inside the inner wrap are sterile and acceptable for use in a sterile field if pouch is unopened and undamaged.

II. COLLECTION PROCEDURE

  1. 1. Close the clamp 3 (clamp 4 should remain open).
  2. 2. After clamping and sectioning of the umbilical cord, place the collection bag on a mixer and perform a venipuncture at lower end of the umbilical cord with needle 1. Note: Umbilical venipunctures can be done before or after the expulsion of the placenta according to your local procedures.
  3. 3. Open clamp 3.
  4. 4. Stimulate cord blood flow by massaging the cord from the top downward to increase volume of collection.
  5. 5. When collection is completed, close clamp 3.
  6. 6. Remove needle 1 and slide down SECUVAM 2 (needle protector) over needle 1.

III. ADDITION OF CORD BLOOD FROM THE TUBE TO THE SAMPLING POUCH

  1. 1. Move clamp 3 at the top of the collection line close to the needle protector 2
  2. 2. Using a blood stripper, strip the tubing from the top of the tube towards the safety ring expelling the blood in the tubing into collection bag 7.
  3. 3. Repeat this operation 3 times.
  4. 4. Mix collection bag 7.
  5. 5. Close clamp 3.

IV. END OF COLLECTION

  1. 1. Close clamp 4 to secure the collection above the safety ring 8.
  2. 2. Seal the tubing above the clamp 4.
  3. 3. Fill in collection volume on the collection bag label.
  4. 4. For optimal cord blood quality, maintain the cord blood at an ambient temperature (18-26°C / 64.4-78.8°F) or cold temperature (4-12°C / 39.2-53.6°F) 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 within 24 hours of collection.

VI. CONTACT INFORMATION

Manufactured for United States of America (U.S.A.) by Maco Productions Polonia, Sp. z o.o. ul. Szwajcarska 22, 54-405 Wroclaw, POLAND +48 71 37 60 110

For consumer information contact:

Distributed by Uneklo USA, Inc., dba Macopharma USA, 3075 Breckinridge Boulevard, Suite 405, Duluth, GA 30096, USA (770) 270-6867

VII. REFERENCES

  1. 1. Pope, B., Mitsakos, K., Bilgin, A., Hokin, B. and Grant, R: Predicting overall viability of cord blood harvests. Transfusion 2012; 52:1079-1085
  2. 2. 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
  3. 3. 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

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 125552 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Sterile Cord Blood Collection Unit (MSC128D)

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Anti-coagulant, Calculi Dissolution Agent
Active ingredients Sodium citrate 0.92 g/35 mL, Dextrose monohydrate 0.89 g/35 mL, Citric acid monohydrate 114.5 g/35 mL, Sodium phosphate, monobasic, dihydrate 87.9 g/35 mL
Dosage form Injection, solution
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) Maco Productions
FDA approval NDA 125552New Drug Application (NDA)
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.92 g/35 mL, 0.89 g/35 mL, 114.5 g/35 mL, 87.9 g/35 mL – 35 ml in 1 kit / 1 in 1 kit NDC 14498-005-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.