Industry-Preferred Cryogenic Freezing Bags Transforming Future Possibilities

Intended Use: The CryoStore FLEX bag is designed to freeze blood components.

Registration

FDA 510(k) Cleared. CE Marked.

OriGen Biomedical sells directly and works with a network of global distributors. For availability in your country, please contact us below.

  • Flexibility

    The CryoStore FLEX Bag can be filled and sealed into separate 4-6ml chambers for flexible utilization post-thaw. A variable number of compartments can be utilized, depending on the number of cells a patient needs. The FLEX bag is designed for scalable dosing and the bag segments can be used to increase doses by incremental amounts.

  • Durability

    The CryoStore FLEX Bag is made of the same robust EVA material as our existing industry-preferred OriGen CryoStore Bags, known for their durability proven through validation and customer success.

  • Representative

    Cell products frozen into the CryoStore FLEX Bag will experience the same conditions as the larger cell product in CryoStore Bags. The FLEX bag is a representative sample of the contents of a CryoStore final cell product bag that can be used for quality assurance testing and dosing.

  • Less Equipment

    FLEX Bags fit into the same cassette as a CryoStore CS50 bag allowing for cold storage next to the final product and eliminating the need for cryovials and cold vial storage. It can be stored in the same rack and same tank as the final cell product.

ML58.R00

Product Use

Product Code

Product Description

Packaging

Case Qty

CS20N N” Tube Set – One male luer with cap, two female luers with caps, roller clamps, and a needle-free injection port Pouch of 4 24
CS20NS N” Tube Set – One male luer with cap, two female luers with caps, roller clamps, and a needle-free injection port

Pouch of 1

(double aseptically packed)

12
CS20F “F” Tube Set – One female luer with cap and pinch clamp Pouch of 4 24

Will freezing bags break or fracture when impacted, dropped, etc. while frozen?

All plastics have a glass transition temperature unique to the identity and grade of polymer that makes up the plastic (it varies but is  -65C to -150C for our materials). Above this temperature, the bags are flexible. However, once the bag is cooled below its glass transition temperature, the films lose their plasticity. Any impact, pinch, cut, etc. can result in a clean fracture that radiates from the point of impact, akin to broken glass. Please see our white paper on How to Prevent Freezing Bag Breaks for more information.

What are the dimensions of a particular CryoStore FLEX Bag?

All sizing information can be found on the product brochure.

What is the expiration date of CryoStore Products?

4 years

I have a problem with a product, what is the complaint procedure?

Please report it as soon as possible. Contact the OriGen head office or your sales representative. Please retain the product and its packaging as this will help us in our investigation and findings. All complaints will receive a written or oral response acknowledging receipt of the product and initial findings.

Where can I find the Instructions for Use (IFU) or Certificate of Conformance (CoC) for the product I received?

An IFU and CoC will be in your original shipment box. If these items are misplaced, you can access the IFU and CoC for your OriGen products through the Client Login. If you do not have a current login, you will need to register for an account through that page.

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