Regulated Software Application (RSA), Version 2.0

Basic Information

• Brand Name: Regulated Software Application (RSA), Version 2.0
• Primary DI: 00860006793708
• Version / Model: 2.0.0.0
• Catalog Number: 2.0.0.0
• Company Name: ARC-ONE SOLUTIONS, LLC
• Labeler DUNS: 117472366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 2
• Public Version Date: 2021-06-09
• Public Version Status: Update
• Public Device Record Key: 5c8a4729-1861-44b8-bffb-082854928c62

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMH	Blood Establishment Computer Software And Accessories	Hematology	864.9165	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44100	Blood bank information system application software	An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute administrative and clinical data within blood-bank centres. It accumulates data on blood-donor status and may include algorithms to process blood-bank information. It may perform additional tasks such as autologous and direct unit tracking, cross-match result determination, and/or management of bar-code information and patient history reports. It is typically supplied for installation into a blood bank information system, or mainframe or decentralized computers/networks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860006793708	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK200512	0