FDA.reportPublic FDA data

PermaLife

Primary DI
10816203021769
Brand
PermaLife
Company
ORIGEN BIOMEDICAL, INC.
Model
PL120M
Device description
PermaLife Cell Culture Bag, 120ml, with 10cm sheath
Published
2016-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816203021769PackageGS110In Commercial Distribution
00816203021762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081620302176910816203021769
00816203021762008162030217628162030217620816203021762

GMDN Terms#

Term, Definition table
TermDefinition
Patient-washing mittenA non-sterile device worn on the hand to wash a patient; it is commonly used by a caregiver to bathe an incapacitated patient. It is typically made of waterproof plastic materials and has a soft exterior surface that may be pre-treated with mild detergent (a soap). The device also serves as a barrier to help prevent cross-contamination between the patient and the caregiver. It is typically used in the intensive care unit (ICU), for oncology patients, and for long-term patients in a healthcare facility or at home. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
512-474-7278regulatory@origen.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
true
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
20816203023623PermaLifeORIGEN 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