INTERCEPT Blood System for Plasma

GUDID 18717953196931

INTERCEPT Blood System for Plasma, Plasma (P) Processing Set

CERUS CORPORATION

Pathogen inactivation/reduction system Pathogen inactivation/reduction system Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit Donor blood photochemical treatment kit

• Primary Device ID: 18717953196931
• NIH Device Record Key: 70c13826-575d-447e-a81a-ebfd3772773e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERCEPT Blood System for Plasma
• Version Model Number: INT3110B
• Company DUNS: 858999485
• Company Name: CERUS CORPORATION
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX
• Phone: 1-855-835-3523
• Email: XXX@XXX.XXX

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717953196934 [Unit of Use]
GS1	0CEINT3110 [Unit of Use]
GS1	18717953196931 [Primary]
GS1	28717953196938 [Package]; Package: Foil Pouch [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BP130076

FDA Product Code

• PJF: Illuminator System For Blood Products

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-15
• Device Publish Date: 2015-01-13

On-Brand Devices [INTERCEPT Blood System for Plasma]

• 18717953196931: INTERCEPT Blood System for Plasma, Plasma (P) Processing Set
• 08720589190108: INTERCEPT Blood System for Plasma, Plasma (P) Processing Set (Semi-Integrated Set)