Sterile Cord Blood Collection Unit

Generic name: anticoagulant citrate phosphate dextrose
Dosage form: solution injection, solution

MACO BIOTECH Collection - Sterile Cord Blood Collection Unit (MSC128D)

The MSC128D Sterile Cord Blood Collection Unit consists of 300 mL collection bag containing 21 mL of Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD), a 40 mL rinsing bag containing 8 mL of CPD and two 12 gauge needles with a 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.

Indications and Usage for Sterile Cord Blood Collection Unit

MSC128D - For collection of up to 200 mL of umbilical cord blood. Use aseptic technique.

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.

Precautions

• DO NOT use if the overwraps or bags show any signs of alteration.
• This is a 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 (18-26°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.

How is Sterile Cord Blood Collection Unit Supplied

MSC128D Sterile Cord Blood Collection Unit contains:

• 300 mL collection bag containing 21 mL CPD
• 40 mL rinsing bag containing 8 mL CPD
• 2-12 gauge needles with a protective shield (SECUVAM) for used needle
• Graduation label as visual aid to approximate the volume.

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...).
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. Close all clamps 3A, 3B and 3C (clamp 9 should remain open).
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 first needle 1A.

Note