INTERCEPT Blood System for Cryoprecipitation

GUDID 38717953197017

INTERCEPT Blood System for Cryoprecipitation

CERUS CORPORATION

Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag

• Primary Device ID: 38717953197017
• NIH Device Record Key: 75cf47e3-e85e-40f1-acf8-92a5613ff82f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERCEPT Blood System for Cryoprecipitation
• Version Model Number: INT3230
• 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: true
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717953197016 [Unit of Use]
GS1	18717953197013 [Primary]
GS1	38717953197017 [Package]; Contains: 18717953197013; Package: foil pouch [8 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-30
• Device Publish Date: 2021-03-22

Devices Manufactured by CERUS CORPORATION

• 08720589190108 - INTERCEPT Blood System for Plasma: 2023-03-01 INTERCEPT Blood System for Plasma, Plasma (P) Processing Set (Semi-Integrated Set)
• 08720589190115 - INTERCEPT Blood System for Platelets: 2023-03-01 INTERCEPT Blood System for Platelets Small Volume (SV) Processing Set (Semi-Integrated Set)
• 28720589190126 - INTERCEPT Blood System for Platelets: 2023-03-01 INTERCEPT Blood System for Platelets Large Volume (LV) Processing Set (Semi-Integrated Set)
• 28720589190133 - INTERCEPT Blood System for Platelets: 2023-03-01 INTERCEPT Blood System for Platelets Dual Storage (DS) Processing Set (Semi-Integrated Set)
• 38717953197017 - INTERCEPT Blood System for Cryoprecipitation: 2021-03-30INTERCEPT Blood System for Cryoprecipitation
• 38717953197017 - INTERCEPT Blood System for Cryoprecipitation: 2021-03-30 INTERCEPT Blood System for Cryoprecipitation
• 18717953196900 - INTERCEPT Blood System for Platelets: 2019-04-15 INTERCEPT Blood System Platelets Small Volume (SV) Processing Set
• 18717953196917 - INTERCEPT Blood System for Platelets: 2019-04-15 INTERCEPT Blood System for Platelets Large Volume (LV) Processing Set
• 18717953196924 - INTERCEPT Blood System for Platelets: 2019-04-15 INTERCEPT Blood System for Platelets Dual Storage (DS) Processing Set