INTERCEPT Blood System for Platelets

GUDID 18717953196924

INTERCEPT Blood System for Platelets Dual Storage (DS) 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: 18717953196924
• NIH Device Record Key: f7f329bc-7fa5-445c-bc94-12d5cac2095d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERCEPT Blood System for Platelets
• Version Model Number: INT2510B
• 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	08717953196927 [Unit of Use]
GS1	0CEINT2510 [Unit of Use]
GS1	18717953196924 [Primary]
GS1	28717953196921 [Package]; Package: Foil Pouch [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BP140143

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 Platelets]

• 28717953196976: INTERCEPT Blood System for Platelets Dual Storage (DS) Processing Set
• 28717953196969: INTERCEPT Blood System for Platelets Large Volume (LV) Processing Set
• 28717953196952: INTERCEPT Blood System for Platelets Small Volume (SV) Processing Set
• 18717953196924: INTERCEPT Blood System for Platelets Dual Storage (DS) Processing Set
• 18717953196917: INTERCEPT Blood System for Platelets Large Volume (LV) Processing Set
• 18717953196900: INTERCEPT Blood System Platelets Small Volume (SV) Processing Set
• 28720589190133: INTERCEPT Blood System for Platelets Dual Storage (DS) Processing Set (Semi-Integrated Set)
• 28720589190126: INTERCEPT Blood System for Platelets Large Volume (LV) Processing Set (Semi-Integrated Set)
• 08720589190115: INTERCEPT Blood System for Platelets Small Volume (SV) Processing Set (Semi-Integrated Set)