ORIGEN GENERAL QUESTIONS

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, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving, Christmas Eve, and Christmas Day. 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.

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

An IFU and CoA will be in your original shipment box. If these items are misplaced, you can access the IFU and CoA 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 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 for use worldwide. Please see the individual product pages for the registration of each device. The 510K numbers are below:

CryoStore: 510(k) number: BK030036
PermaLife and CryoBag: 510(k) number: K021702
OriGen ECLS catheter: 510(k) number: K003288
OriGen Reinforced Dual Lumen Cannula: 510(k) number: K113869
PVC: 510(k) number: BK140116

Additional Accreditation Information:

FDA Website

FDA Establishment Registration & Device Listing PDF

ISO 13485 Certificate

CE Certificate Bag Products

CE Certificate Liquivent Lavage Solutions

GTIN Database – OriGen

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 or Canada?

To purchase outside the USA or Canada, 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 and Canada), 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.

What are OriGen's lead times?

Stock Items will ship within 3 business days.

Non-Stock Items products have an 8-12 week lead time from receipt of the purchase order. Contact the US headquarter or your sales representative for minimum quantity details.

Who is my Account Manager in the USA or Canada?

OriGen Biomedical has sales representatives for cell culture and cryopreservation products in the USA and Canada.  The representatives are Wayne Whitlock (Northeast), Diann Fisk (Southeast), Ray Rendon (Central and Southwest), Donna King (West) and Lianne Witt (Canada). Please contact your sales representatives directly for quotes and questions regarding ordering. If you are unsure how to contact your representative, please contact the US headquarters for contact information.

ECMO products do not have a sales representative. Please contact the OriGen office for questions and quotes.

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.

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 business days.

Non-Stock Items products have an 8-12 week lead time from receipt of the purchase order. Contact the US headquarter or your sales representative for minimum quantity details.

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.

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.

CRYOSTORE & ACCESSORY SETS

Why do CryoStore bags fracture like glass when impacted, dropped, etc?

All plastics have a glass transition temperature unique to the identity and grade of polymer that makes up the plastic (it varies but is -110C to -150C for our materials). Above this temperature, the bags are flexible but once the bag is cooled below its glass transition temperature, the films lose their plasticity and begin to act like panes of glass. Any impact, pinch, cut, etc. can result in a clean fracture that radiates from the point of impact, akin to a cracked window.

What is the expiration date of CryoStore products?

CryoStore Bags and Accessory Sets: 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 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.

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

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

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?

CryoPur Solutions: 3 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 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.

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

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

PERMALIFE CELL CULTURE BAGS

In cell culture - what is the benefit of using a bag vs a flask?

Bags create a closed system that reduces possibility of contamination. Swabbable needle-free valves are provided that provide repeated sterile access (and prevent needle-sticks). Our cell culture bags have 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?

PermaLife 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 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.

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

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

EVOLVE CELL CULTURE BAGS

In cell culture - what is the benefit of using a bag vs a flask?

Bags create a closed system that reduces possibility of contamination. Swabbable needle-free valves are provided that provide repeated sterile access (and prevent needle-sticks). Our cell culture bags have 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?

Evolve 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 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.

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

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

ORIGEN REINFORCED DUAL LUMEN CATHETERS & ANCILLIARY PRODUCTS

Is the VV13F in stock?

The OriGen Biomedical Reinforced Dual Lumen Catheter in 13F is currently not in stock. The product will be available by the end of 2018.

Is the VV19F in stock?

The OriGen Biomedical Reinforced Dual Lumen Catheter in 19F is currently not in stock. The product will be available by the end of 2018.

Do you have percutaneous introducer (PCT) kits?

A PCT Kit is available for all OriGen Catheter sizes (13F-32F).

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

Catheters and Ancillary ECMO 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 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.

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

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

LIQUIVENT & LIQUIVENT-D

What is the difference between the two types of perfluorocarbons (PFC's)?

Perfluorooctylbromide is radiopaque and slightly higher priced than Perfluorodecalin which is radiolucent.

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?

Liquivent Products: 3 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 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.

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

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