ORIGEN GENERAL QUESTIONS

What Regulatory approvals does OriGen have?

We are ISO 13485 Certified, plus our medical devices have received marketing clearance from FDA, are CE-marked, and are generally approved in many other markets worldwide. Please see the individual product pages for the registration of each device.

Additional Regulatory and Accreditation Information can be found on our Regulatory page.

What conferences will OriGen Biomedical attend this year?

What are OriGen’s Hours?

OriGen is open from 8:00AM CT to 4:30PM CT, Monday through Friday. OriGen is closed for New Year’s Day, Memorial Day, Juneteenth Day, Independence Day, Labor Day, Thanksgiving Day, Day After Thanksgiving, Christmas Eve, Christmas Day, and New Year’s Eve. Orders will be delayed slightly around these holidays.

Is OriGen Biomedical hiring?

Please see our Careers Page.

Does OriGen contribute to any non-profits or participate in grants?

OriGen supports BIO Austin and the Texas Medical Device Association. OriGen supports various conferences throughout the year through sponsorship.

How can I become a distributor for your product?

Please contact the Head Office at +1-512-474-7278 or complete the form here.

ORDERING

How can I purchase product from outside the United States, Canada, or the United Kingdom?

To purchase outside the USA, Canada, or the UK you need to contact the distributor in your country. If you do not know who your distributor is, please click here to reach a distributor contact.

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.

How do I submit an order?

You may submit the form located here, email sales.us@origen.com, call +1-512-474-7278, or fax 512-617-1503 or toll-free 1-888-812-8411. It is best to have your purchase order available to you at that time.

Will I receive an order confirmation?

An order confirmation will be sent to the email of the company contact who submitted the order. Please check your email.

I ordered an incorrect item/too much of an item, how do I submit for a return?

Please contact customer service at 512-474-7278 or through the contact form here. The return may be subject to a 20% restocking fee.

The package I received is damaged, who do I contact?

Please contact customer service directly to report damaged or lost shipments at 512-474-7278 or through the contact form. Further instruction would be given to customer regarding how to return damaged products and when to expect replacement product.

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 Account Manager. 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.

SHIPPING & LOGISTICS

What are my options for shipping?

OriGen can ship with your preferred carrier. Typically, OriGen will ship through FedEx Ground. OriGen can expedite your order through 2nd Day, 2nd Day Air, Next Day, and Next Day AM at your cost. Orders must be submitted by 2PM CT.

What are OriGen's lead times?

Stock Items will ship within 3-5 business days.

Non-Stock Items products have a 16-week lead time from receipt of the purchase order. Contact the US headquarters or your sales representative for minimum quantity details.

What is the difference between stock and non-stock?

Stock items are ready to ship within 3 business days.
Non-stock items take 16 weeks to produce with a required minimum order quantity.

Will I receive a shipping confirmation?

A shipping confirmation email will have been sent to the company contact on file. Please check your  email. OriGen may provide a fax confirmation if no email is available.

TECHNICAL INFORMATION

Where can I find the Instructions for Use (IFU), Certificate of Analysis (CoA), or Certificate of Compliance (CoC) for the product I received?

An IFU, CoA, or CoC will be in your original shipment box. If these items are misplaced, you can access the IFU, CoA, 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.

What are the dimensions of a particular product?

All sizing information can be found on the product brochure.

Where can I find Technical Bulletins?

Technical product information, including Technical Bulletins, can be found here. You must be logged into your OriGen account to access this information. If you do not have an account, please register an account here and it will be approved within 2-3 business days

CRYOSTORE & ACCESSORY SETS

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 is the expiration date of CryoStore products?

4 years

CRYOPUR DMSO SOLUTIONS

My CryoPur DMSO Solution is frozen - is it defective?

Not defective at all. Although DMSO has the consistency and transparency of water, its melting point is 19C (or 66F). At a standard room temperature of 75F, your DMSO will be a liquid but if it has been shipped in the cold or kept in a chilly room, it will have frozen. There is no need to place the DMSO vials or syringes into a water bath – just leave them out at room temperature and they will thaw quickly.

What is the expiration date of CryoPur products?

3 years

PERMALIFE CELL CULTURE BAGS

In cell culture - what is the benefit of using a closed system?

Bags create a closed system that reduces the possibility of contamination. Swabbable needle-free valves are provided that provide repeated sterile access (and prevent needle-sticks). Our cell culture bags have a high optical transmission that allows for inspection of contents without risking contamination of the culture. The bags are gas permeable and provide high rates of oxygen transfer to cells under culture. Additionally, water permeability is very low, so water loss is negligible and humidifed incubators are not required.

What is the expiration date of PermaLife products?

4 years

EVOLVE CELL CULTURE BAGS

In cell culture - what is the benefit of using a closed system?

Bags create a closed system that reduces the possibility of contamination. Swabbable needle-free valves are provided that provide repeated sterile access (and prevent needle-sticks). Our cell culture bags have a high optical transmission that allows for inspection of contents without risking contamination of the culture. The bags are gas permeable and provide high rates of oxygen transfer to cells under culture. Additionally, water permeability is very low, so water loss is negligible and humidifed incubators are not required.

What is the expiration date of Evolve products?

4 years

TUBE SEALER CR6

What is the difference between the CR6 and the CR6-P?

The only difference is that CR6 Sealer has a smooth seal, and the CR6-P has a perforated seam through the seal.

What is the delivery date for the equipment?

Shipment is generally within two weeks after the order is placed.

Where can I find replacement parts?

OriGen offers many spare parts, including replacement batteries, battery chargers, handles, and cables. Please contact us for additional parts.

What materials can be sealed with the CR6?

It can seal PVC, PVC/EVA co-extrusions, and most EVA tubing with a nominal diameter of 4 mm.

What is the width of the seal?

The width of the seal is fixed at about 3 mm.

What are the main power supply specifications?

The CR6 is battery operated (NiMh battery pack 24V/ 3,8Ah).

How many seals can I get with fully a fully charged battery?

With a new and fully charged battery, the CR6 can make approximately 1,500 seals in 4-5 mm PVC tubes on one charge. This high capacity makes the CR6 suitable for use in a mobile or stationary capacity. However, the sealer should cool at least one minute after making multiple seals to produce consistent, reliable seals.

How long does it take the battery to charge?

A battery with a capacity of 25% (red LED) requires 6-8 hours to fully charge.

How long should the included batteries last?

The working life of the batteries depends on the number of recharge cycles, the surrounding temperature, and the temperature rise that occurs when batteries
are charging. The typical expected working life is 3 years with a charging frequency of 200 cycles per year at 25ºC. Deep discharging (allowing the battery to be at 0-5% capacity) or overcharging (leaving the system plugged in continuously) will shorten the battery life.

What type of functional testing is done before the unit is shipped?

We do five test seals of each type of tubing, before sending the product out. Every seal sample is QA checked before the unit is boxed up and closed.

Is there a warranty for the CR6?

The manufacturer provides a one-year warranty from the date of delivery from OriGen.

LIQUIVENT® LUNG LAVAGE SOLUTIONS

How quickly does it evaporate?

When used for bronchial lavage, it is instilled into the lungs and suctioned back out.

What is a normal dosage?

10-20cc/kg for bronchial lavage.

How do I access Liquivent® for research purposes?

Please contact customer service at 512-474-7878, submit a quote request form, or email info@origen.com for pricing and availability. 

What is the expiration date of Liquivent® Products?

3 years

ORIGEN REINFORCED DUAL LUMEN CATHETERS & ANCILLIARY PRODUCTS

Where can I find more information regarding the OriGen RDLC ECMO Catheter recall?

Information regarding the recall can be found here. If you have a product that was recalled and would like additional information regarding returning the product, please contact OriGen through the contact information page.

Are any RDLC ECMO products in stock?

No, OriGen has discontinued the OriGen Biomedical RDLC product line including VV13F, VV16F, VV19F, VV23F, VV28F, and VV32F.

What is the expiration date of Catheters and Ancillary ECMO Products?

4 years

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