Origen ae TissueVault Series Instructions For Use

CAUTION: US Federal law restricts the sale and use of this device
by or on the order of a physician.
Disclaimer of Warranties
OriGen Biomedical warrants that reasonable care has been used in the manufacture of this
device and that it was free from defects in workmanship or materials at the time of
shipment from OriGen. OriGen's sole obligation shall therefore be to repair or replace any
device which it determines was defective at the time of shipment. Because no product is
completely effective under all circumstances, and because the actual use and handling of
this device is beyond our control, OriGen cannot warrant for a good effect or against a bad
effect in the application and use of this device. The buyer therefore assumes all liability
arising from any cause for damages resulting from use, misuse or resterilization of this
product. OriGen therefore gives no warranty of merchantability or fitness for a particular
purpose. OriGen shall not be liable for incidental or consequential loss, damage or expense
resulting from the use or application of this product. This warranty is in lieu of all other
warranties, whether implied, express, oral or written, and no individual has the authority to
vary the terms of this warranty.
OriGen Biomedical, Inc.
7000 Burleson Rd, Bldg D
Austin, TX, USA 78744
Tel: +1 512 474 7278
Fax: +1 512 617 1503
Email: sales.us@origen.com
www.origen.com
LC44. R05: 2019-01, OriGen Biomedical, Inc. All Rights Reserved
European Representative
Advena Ltd.
Tower Business Centre
2 Flr, Tower Street,
nd
Swatar, BRK 4013 Malta
OriGen TissueVault Tissue Freezing Bag
Instructions for Use
Indications
The OriGen TissueVault Tissue Freezing Bags are indicated for
use in freezing cells and tissues. For single use only. Contraindicated
for other uses.
Sterile
Products are sterile, singly packed. Sterilized with Radiation.
WARNING: Re-sterilization may damage the product. Re-use
may cause contamination or viral transmission between tissues.
Product Characteristics
Materials:
The OriGen TissueVault is made of EVO copolymer. This
material is easily sealed and remains flexible in liquid nitrogen.
Contains no phthalates, BPA, or latex.
The TissueVault is supplied as a flat pouch with one end open,
and is designed to freeze solid tissue and bone.
Gas permeable:
The TissueVault bag is gas permeable, but water vapor
transmission rates are very low. Gas transfer rates for O2, H2O and
CO2 under ideal conditions are as follows:
79.2g/day
Oxygen
654g/day
CO2
H2O 4.4 g / day
TV0918 TV1430
429g/day
3.5 kg / day
2.28 g / day