CryoStore FLEX Bag

All plastics have a glass transition temperature unique to the identity and grade of the polymer that makes up the plastic. OriGen Biomedical products have a glass transition temperature between -65°C to -150°C. Above this temperature, the bags are flexible. However, once the bag is cooled below its glass transition temperature (our products can be frozen down to -196°C), 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.

Freeze/Fill Volume per Chamber = 4-6ml
Freeze/Fill Volume per Bag = 20-30ml

4 years from sterilization

Please see our product code definitions located here.

~2.4″ in height and ~0.8″ wide

For the ‘N’ tube set, the tubing between the Y-component and the luers is PVC and is weldable. The tubing from the NFV to Y-component is also PVC, but has a different diameter, which is not weldable to standard tubing.

For other tube sets, please reference the Technical Data Sheets to determine the material of the tubing present and its compatibility with welding.

Please contact your OriGen Account Manager (USA, Canada, or UK), your local distributor (international), or OriGen Biomedical if you are unsure of who to contact through the form here or by calling +1-512-474-7278.

CryoStore bags are not specific to any one cell line. They are intended to provide protection during cryopreservation for blood components. Users should validate specific blood or blood components per their institutional protocols.

When available, most orders ship within 2-3 business days. Some international orders may take 3-5 business days for shipment. Special order items will always be manufactured to order, with minimum quantities and a lead time.

CryoStore bags are validated to maintain integrity in direct liquid nitrogen and are therefore able to be frozen at temperatures found in both in liquid and in vapor phases: -196°C (-321°F). Please follow institutional protocols to determine the phase of nitrogen that best suits your needs.

OriGen does not indicate the CryoStore bags for specific applications. The patient group is not a factor in the clinical use of the CryoStore Freezing Bags as the products are not intended for use with any specific patient population, disease state, clinical stage of disease, nor patient condition. Our existing customers commonly use the CryoStore bags for:
• Cell Therapy and Gene Therapy
• Regenerative Medicine
• Immuno-oncology
• Personalized Medicine
• Research and Development
• Storage and Shipping of Biological Materials

Store in a cool, dry area (typically 15°C – 30°C), but users should define and validate their specific space and assign ranges suitable for their conditions. Do not use if the product is damaged. Do not re-sterilize. For single use only.

All products that are labeled “double aseptically packed” are delivered with each device packaged individually inside two sterile barrier pouches. Product codes with in an ‘S’ indicate that they are double aseptically packed.

OriGen Biomedical CryoStore bags have been manufactured to fit inside most standard cassette sizes. Please refer to the cassette manufacturer for details.

All components currently used in OriGen Biomedical product lines are rated for exposure to solutions containing a concentration of 80% DMSO or less. If using DMSO, dilute to less than 60% concentration before use.

If you encounter any issues with an OriGen Biomedical product and wish to file a complaint, we encourage you to do so ASAP. Please contact the OriGen head office or reach out to your dedicated sales representative for assistance. To facilitate our investigation and resolution process, we kindly ask that you retain both the product and its packaging. This will aid us in conducting a thorough analysis of the matter. All complaints will be acknowledged, and OriGen will follow up as appropriate during the investigation. Your feedback is invaluable to us as we strive to maintain the highest standards of quality and customer satisfaction.

Any adverse event related to the device should immediately be reported to OriGen Biomedical or its authorized distributor, the competent local authority, and any other regulators as required by telephone, fax, or letter. This includes an incident or risk of a serious incident liable to result in, or to have resulted in, the death or serious deterioration in the health condition of a patient or user. All complaints should be accompanied by the name(s), reference(s), and batch number(s) of the component(s) and the name and address of the claimant, the nature of the complaint with as much detail as possible, and the indication of a requested response. OriGen Biomedical is located at 2215 Grand Avenue Parkway, Austin, TX, USA 78728-3812 (Tel: +1-512-474-7278, Email: sales.us@origen.com).

OriGen has transitioned to using Electronic Instructions for Use (eIFUs). They are available at ifu.origen.com. Your CoA or CoC will be included with your original shipment box and can also be accessed through the Client Login. If you do not have a current Client Login, you will need to register for an account to access these documents.