Variety of Mechanisms to Access CryoStore Bags

Intended Use: The OriGen Biomedical® Accessory Sets are accessories intended to be used for fluid transfer. 

Registration

FDA 510(k) Exempt. CE Marked.

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

  • Individually Packaged & Sterile

    Spike Adapters are packed individually in a Tyvek® peel pouch and sold sterile. You will only need to open the product you need when you need it, potentially reducing waste.

  • DMSO-Resistant

    When indicated on product labeling, some OriGen Biomedical® spike adapters are 100% DMSO resistant to enhance the reliability of your cryopreservation process.

  • Ease of Use

    Intuitive product design with variations to provide the easiest access to OriGen Biomedical® products, including CryoStore Freezing Bags.

  • Leak-Proof Design

    Engineered to provide a secure, leak-proof connection when used with OriGen Biomedical spike ports, maintaining sample integrity and preventing contamination.

ML45.R06

Interested in Spike Adapters?

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Product Use

Product Code

Description

Case Qty

 

CBS One spike with needle-free valve, 100% DMSO Resistant 50  
IBS One spike with needle injection site 50  
VSV Vial spike with needle-free valve, 100% DMSO Resistant 10  
2P-S16 Two spike ports to one spike with 16cm SCD tubing 20

Special Order

2S-P20 Two spikes to one spike port with 20cm SCD tubing and pinch clamps 20  
S-38B12 One spike to one 3/8″ barb with 12cm DMSO resistant tubing, 100% DMSO Resistant 25  
S-F10 One spike to one female luer with 10cm of tubing and pinch clamp, 100% DMSO Resistant 50  
S-F50 One spike to one female luer with 50cm SCD tubing and pinch clamp 50  
S-FFP12 One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps 20  
S-M50 One spike to one male luer with 50cm SCD tubing and pinch clamp 50  

What is the expiration date of Spike Adapters?

4 years from sterilization

How do I obtain pricing?

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.

What are OriGen's lead times?

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.

Are Spike Adapters DMSO-resistant?

All components currently used in OriGen Biomedical product lines are rated for exposure to solutions containing a concentration of 80% DMSO or less. When indicated on product labeling, some OriGen Biomedical® spike adapters are 100% DMSO resistant to enhance the reliability of your cryopreservation process. For a complete list of the materials used in the product, please refer to the Product Technical Data Sheet. For information on the compatibility of each material with DMSO, please refer to our white paper DMSO Compatibility with Medical Plastics WP1411.

Can they work with non-OriGen Biomedical products?

OriGen has validated luer connectors on the Spike Adapters to be compatible with luer adaptors on other OriGen products. The bag spikes have been validated to spike all ports available on other OriGen product lines. OriGen has not validated the compatibility of the luers or spikes with non-OriGen products and would encourage users to validate their comptability.

What is the recommended storage for Spike Adapters?

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.

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

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.

How do I report an adverse event?

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).

Where can I find the Instructions for Use (IFU), Certificate of Analysis (CoA), Certificate of Conformance (CoC), and/or Safety Data Sheet (SDS) for the product I received?

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.

Is it okay to use the Cell Connect if some of the components have changed color?

Is it okay to use the Cell Connect if some of the components have changed color?

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