PermaLife

Basic Information

• Brand Name: PermaLife
• Primary DI: 00816203021762
• Version / Model: PL120M
• Company Name: ORIGEN BIOMEDICAL, INC.
• Labeler DUNS: 625272232
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-27
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 3ebbc49d-0ad4-41c6-b558-ccc1373700f0

Device Description

PermaLife Cell Culture Bag, 120ml, with 10cm sheath

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: Yes
• 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
47304	Patient-washing mitten	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816203021769	GS1	Case	10	In Commercial Distribution
Primary	00816203021762	GS1

Customer Contacts

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