Regulated Software Application (RSA), Version 2.0 2.0.0.0

GUDID 00086000679378

Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.

ARC-ONE SOLUTIONS, LLC

Blood bank information system application software

• Primary Device ID: 00086000679378
• NIH Device Record Key: 5c8a4729-1861-44b8-bffb-082854928c62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regulated Software Application (RSA), Version 2.0
• Version Model Number: 2.0.0.0
• Catalog Number: 2.0.0.0
• 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: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com
• Phone: 754-837-8835
• Email: jared.mcdonley@arc-one.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00086000679378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK200512

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: 2021-05-10
• Device Publish Date: 2021-04-30

On-Brand Devices [Regulated Software Application (RSA), Version 2.0]

• 00086000679378: Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer
• 00860006793708: Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer