Regulated Software Application (RSA) 1.0.33.0

GUDID 00860003545409

The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of the blood banking process.

ARC-ONE SOLUTIONS, LLC

Blood bank information system application software

• Primary Device ID: 00860003545409
• NIH Device Record Key: 65e232db-0c6c-4f25-be06-bd612f8a8f02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regulated Software Application (RSA)
• Version Model Number: 1.0.33.0
• Catalog Number: 1.0.33.0
• Company DUNS: 117472366
• Company Name: ARC-ONE SOLUTIONS, LLC
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com
• Phone: 17548378835
• Email: jared.mcdonley@arc-one.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003545409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK110048

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: 2020-04-27
• Device Publish Date: 2020-04-17

Devices Manufactured by ARC-ONE SOLUTIONS, LLC

• 00860006793708 - Regulated Software Application (RSA), Version 2.0: 2021-06-09 Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that
• 00086000679378 - Regulated Software Application (RSA), Version 2.0: 2021-05-10 Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that
• 00860003545409 - Regulated Software Application (RSA): 2020-04-27The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of the blood banking process.
• 00860003545409 - Regulated Software Application (RSA): 2020-04-27 The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all