HCLL

GUDID B105HCLL0

HCLL 2015R2 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.HCLL 2015R2 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT 128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional) HCLL 2015R2 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WELLSKY CORPORATION

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• Primary Device ID: B105HCLL0
• NIH Device Record Key: d8e6d453-b18b-40a5-a682-8decc3058402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HCLL
• Version Model Number: 2015R2
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B105HCLL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK160066

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: 2023-06-20
• Device Publish Date: 2023-06-12

Devices Manufactured by WELLSKY CORPORATION

• B105TRANSFUSION20240 - WellSky Transfusion: 2023-12-22 WellSky Transfusion 2024 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There i
• B105TRANSFUSION2023 - WellSky Transfusion: 2023-12-14 WellSky Transfusion 2023 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There i
• B105BLOODCENTERS2018 - WellSky Blood Centers: 2023-06-20 Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the managem
• B105HCLL0 - HCLL: 2023-06-20HCLL 2015R2 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.HCLL 2015R2 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT 128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional) HCLL 2015R2 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
• B105HCLL0 - HCLL: 2023-06-20 HCLL 2015R2 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware
• B105LIFETRAK0 - LifeTrak: 2023-06-20 LifeTrak 2012 is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the managem
• B105BLOODCENTERS2023 - WellSky Blood Centers: 2023-05-22 Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the managem
• B105BLOODCENTERS0 - WellSky Blood Centers: 2022-02-18 Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the managem
• B105TRANSFUSION0 - WellSky Transfusion: 2022-02-18 WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There i