ADIMS

GUDID 00860007397615

ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs

Csl Plasma Inc.

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• Primary Device ID: 00860007397615
• NIH Device Record Key: 8758f82a-026d-4b16-8c43-95181ce6ca80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADIMS
• Version Model Number: 1.0
• Company DUNS: 112132795
• Company Name: Csl Plasma Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: false
• 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
GS1	00860007397615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK190430

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: 2022-01-18
• Device Publish Date: 2022-01-10

Devices Manufactured by Csl Plasma Inc.

• 00860007397615 - ADIMS: 2022-01-18ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs
• 00860007397615 - ADIMS: 2022-01-18 ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and w
• 00860007397608 - LOGIC: 2021-08-23 LOGIC 4.0 is a web-based software application used to support daily operations of product logistics, primarily organizing and co