PermaLife™ Cell Culture Bag

Basic Information

• Brand Name: PermaLife™ Cell Culture Bag
• Primary DI: 10816203023930
• Version / Model: PL30-2G
• Catalog Number: PL30-2G
• Company Name: ORIGEN BIOMEDICAL, INC.
• Labeler DUNS: 625272232
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-18
• Public Version: 2
• Public Version Date: 2026-01-21
• Public Version Status: Update
• Public Device Record Key: 41e45cfe-bbd5-4174-b3d2-755026641273
• Distribution End Date: 2026-01-20

Device Description

PermaLife Cell Culture Bag, 30 mL - no green vent cap

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPZ	Container, Frozen Donor Tissue Storage	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
44904	Blood/tissue storage/culture container	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20816203023937	GS1	Carton	30	Not in Commercial Distribution	2026-01-20
Primary	10816203023930	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K021702	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Do not re-use
• Type: Special Storage Condition, Specify
• Special Conditions: Do not resterilize
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged