INTERCEPT Blood System for Platelets

GUDID 28717953196969

INTERCEPT Blood System for Platelets Large Volume (LV) Processing Set

CERUS CORPORATION

Donor blood photochemical treatment kit

• Primary Device ID: 28717953196969
• NIH Device Record Key: 51bc321c-f4d4-4d3b-9ad3-10a58fa47725
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERCEPT Blood System for Platelets
• Version Model Number: INT2230B
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717953196965 [Unit of Use]
GS1	18717953196962 [Primary]
GS1	28717953196969 [Package]; Contains: 18717953196962; Package: Shipping Carton Box [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: 2018-05-07

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)