FDA.reportPublic FDA data

PermaLife

Primary DI
20816203023623
Brand
PermaLife
Company
ORIGEN BIOMEDICAL, INC.
Model
PL325T
Catalog number
PL325T
Device description
PermaLife Cell Culture Bag, 325ml, with SCD Tubing
Published
2021-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPZContainer, Frozen Donor Tissue Storage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPZContainer, Frozen Donor Tissue StorageUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021702000CRYOBAG, MODEL CBOrigen Biomedical, Inc.2002-08-06LPZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816203023623PackageGS110In Commercial Distribution
10816203023626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081620302362320816203023623
1081620302362610816203023626

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, 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. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
625272232
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816203023848AccessoriesVSVVSV2025-06-18
10816203023916O-Wrap™ BagOW0909OW09092025-06-18
10816203024012TissueVault™ Cell & Tissue Freezing BagTV0909TV09092025-06-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816203023923PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203023930PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024104PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024128PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024340PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024357PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203023920PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203023937PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024101PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024125PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024347PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024354PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203023657PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023664PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023671PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023688PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023695PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023701PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023718PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023602PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023619PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023626PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023633PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023596PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023609PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023616PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023630PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
00817827023019Cell FreezeCHARTER MEDICAL, LTD.LPZ2021-08-23
00817827023026Cell FreezeCHARTER MEDICAL, LTD.LPZ2021-08-23
00817827023033Cell FreezeCHARTER MEDICAL, LTD.LPZ2021-08-23