INTERCEPT Blood System for Plasma

Basic Information

• Brand Name: INTERCEPT Blood System for Plasma
• Primary DI: 18720589190105
• Version / Model: INT3140B
• Company Name: CERUS CORPORATION
• Labeler DUNS: 858999485
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2023-02-21
• Public Version: 1
• Public Version Date: 2023-03-01
• Public Version Status: New
• Public Device Record Key: 3fdefa75-bbba-49a6-accd-4a730c768376

Device Description

INTERCEPT Blood System for Plasma, Plasma (P) Processing Set (Semi-Integrated Set)

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
PJF	Illuminator System For Blood Products	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63003	Donor blood photochemical treatment kit	A collection of sterile devices and reagent solution intended to be used in vitro with an ultraviolet (UV) blood illuminator for photochemical treatment of donor blood (including whole blood, plasma, and/or platelet concentrates) to inactivate blood transfusion-associated pathogens and white blood cells, and for subsequent storage. It includes plastic illumination and storage bags and tubing, and a photoactive reagent (e.g., riboflavin, psoralen) solution; a sampling bag for quality control and a compound adsorption device used post-irradiation to reduce the levels of photoactive reagent in the final suspension may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	08720589190108	GS1
Primary	18720589190105	GS1
Package	28720589190102	GS1	Shipping Carton Box	4	In Commercial Distribution

Customer Contacts

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