FDA.reportPublic FDA data

TissueVault™ Cell & Tissue Freezing Bag

Primary DI
10816203024012
Brand
TissueVault™ Cell & Tissue Freezing Bag
Company
ORIGEN BIOMEDICAL, INC.
Model
TV0909
Catalog number
TV0909
Device description
TissueVault, Cell and Tissue Freezing 9x9cm bag
Published
2025-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816203024019PackageGS1100Not in Commercial Distribution
10816203024012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081620302401920816203024019
1081620302401210816203024012

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not re-use
Special Storage Condition, Specify00Do not resterilize
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+1-512-474-7278regulatory@origenbio.com

Regulatory Flags#

DUNS number
625272232
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816203023848AccessoriesVSVVSV2025-06-18
10816203023916O-Wrap™ BagOW0909OW09092025-06-18
10816203024074Evolve Cell Culture BagEV120 + F-M12EV120 + F-M122025-06-18
10816203024098O-Wrap™ BagOW0918OW09182025-06-18
10816203024159TissueVault™ Cell & Tissue Freezing BagTV0918TV09182025-06-18
10816203023923PermaLife™ Cell Culture BagPL07-2GPL07-2G2025-06-18
10816203023930PermaLife™ Cell Culture BagPL30-2GPL30-2G2025-06-18
10816203024104PermaLife™ Cell Culture BagPL30MPL30M2025-06-18
10816203024128PermaLife™ Cell Culture BagPL70-2GPL70-2G2025-06-18
10816203024340PermaLife™ Cell Culture BagPL120NPL120N2025-06-18
10816203024357PermaLife™ Cell Culture BagPL120-2GPL120-2G2025-06-18
10816203023855Accessories15-R3FT15-R3FT2025-06-18
10816203023862Accessories15-R6F-TA15-R6F-TA2025-06-18
10816203023879Accessories15-RF12-T15-RF12-T2025-06-18
10816203023886Accessories15-RF20-T15-RF20-T2025-06-18
10816203023947AccessoriesR3F-T15R3F-T152025-06-18
10816203023961AccessoriesS-F10S-F102025-06-18
10816203023978AccessoriesS-F50S-F502025-06-18
10816203023985AccessoriesS-FFP12S-FFP122025-06-18
10816203023992AccessoriesS-M50S-M502025-06-18

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Primary DI, Brand, Company table
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H108117041CorningCorning IncorporatedFMH2025-10-28
10192253051490DoverCardinal Health 200, LLCFMH2025-09-30
10192253051513DoverCardinal Health 200, LLCFMH2025-09-30
10198459304637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
10198459382963MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
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10198459277122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-02
10192253051636PrecisionCardinal Health 200, LLCFMH2025-02-19
10198459247897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10198459249303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10197344039517MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-01-31
10198459203176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-12-08
10198459190544Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-24
10198459179860Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
10198459181702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29
H1084316231CorningCorning IncorporatedFMH2024-10-29
H1084316241CorningCorning IncorporatedFMH2024-10-29