WellSky Blood Centers

GUDID B105BLOODCENTERS2023

Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols

WELLSKY CORPORATION

Blood bank information system application software

• Primary Device ID: B105BLOODCENTERS2023
• NIH Device Record Key: 5f35bec2-6979-44ba-8113-243a9fa399ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WellSky Blood Centers
• Version Model Number: 2023
• Company DUNS: 177240249
• Company Name: WELLSKY CORPORATION
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B105BLOODCENTERS2023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK180200

FDA Product Code

• MMH: Blood Establishment Computer Software And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-22
• Device Publish Date: 2023-05-12

On-Brand Devices [WellSky Blood Centers]

• B105BLOODCENTERS2019: Blood Centers is a comprehensive, modular, computerized system intended to be used by trained p
• B105BLOODCENTERS0: Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe
• B105BLOODCENTERS2023: Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe
• B105BLOODCENTERS2018: Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe
• B10520241: Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe