TissueVault™ Cell & Tissue Freezing Bag TV0909

GUDID 20816203024019

TissueVault, Cell and Tissue Freezing 9x9cm bag

ORIGEN BIOMEDICAL, INC.

Blood/tissue storage/culture container
Primary Device ID20816203024019
NIH Device Record Key70161aeb-af8d-438f-be6c-2ece31483738
Commercial Distribution StatusIn Commercial Distribution
Brand NameTissueVault™ Cell & Tissue Freezing Bag
Version Model NumberTV0909
Catalog NumberTV0909
Company DUNS625272232
Company NameORIGEN BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize

Device Identifiers

Device Issuing AgencyDevice ID
GS110816203024012 [Primary]
GS120816203024019 [Package]
Contains: 10816203024012
Package: Carton [100 Units]
In Commercial Distribution

FDA Product Code

FMHContainer, Specimen, Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-26
Device Publish Date2025-06-18

On-Brand Devices [TissueVault™ Cell & Tissue Freezing Bag]

20816203024156TissueVault, Cell and Tissue Freezing 9x18cm bag
20816203024019TissueVault, Cell and Tissue Freezing 9x9cm bag

Trademark Results [TissueVault]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TISSUEVAULT
TISSUEVAULT
98492743 not registered Live/Pending
OriGen Biomedical, Inc.
2024-04-10

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.