INTERCEPT Blood System for Plasma

Basic Information

• Brand Name: INTERCEPT Blood System for Plasma
• Primary DI: 18717953196993
• Version / Model: INT3130B
• Company Name: CERUS CORPORATION
• Labeler DUNS: 858999485
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-11-09
• Public Version: 1
• Public Version Date: 2020-11-17
• Public Version Status: New
• Public Device Record Key: 059e5723-2302-42f1-b8d8-5f7ed8b7a4fd

Device Description

INTERCEPT Blood System for Plasma, Plasma (P) Processing 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
Package	28717953196990	GS1	foil pouch	4	In Commercial Distribution
Unit of Use	08717953196996	GS1
Primary	18717953196993	GS1

Customer Contacts

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