FDA.reportPublic FDA data

Regulated Software Application (RSA)

Primary DI
00860003545409
Brand
Regulated Software Application (RSA)
Company
ARC-ONE SOLUTIONS, LLC
Model
1.0.33.0
Catalog number
1.0.33.0
Device description
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.
Published
2020-04-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMHBlood Establishment Computer Software And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMHBlood Establishment Computer Software And AccessoriesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1100480

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1100480

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003545409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003545409008600035454098600035454090860003545409

GMDN Terms#

Term, Definition table
TermDefinition
Blood bank information system application softwareAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
17548378835jared.mcdonley@arc-one.com

Regulatory Flags#

DUNS number
117472366
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006793708Regulated Software Application (RSA), Version 2.02.0.0.02.0.0.02021-04-30
00086000679378Regulated Software Application (RSA), Version 2.02.0.0.02.0.0.02021-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142373807SoftBankSCC SOFT COMPUTERMMH2026-04-29
1928342896382100Donor-IDHEALTHCARE ID, INC.MMH2026-04-10
00860010612873SDNet Configurable Manual Batch EntryRubin & Poor, Inc.MMH2026-01-27
B236SQBB202420Clinisys SQ Blood BankCliniSys, IncMMH2026-01-23
B105TRANSFUSION20250WellSky TransfusionWELLSKY CORPORATIONMMH2026-01-14
03665324000067Patient Health Software (P.H.S)MAK-SYSTEM GROUP LIMITEDMMH2025-12-15
B180IMB029010Instrument ManagerDATA INNOVATIONS LLCMMH2025-12-08
00860271000969VistA Blood Establishment Computer SoftwareVETERANS AFFAIRS, UNITED STATES DEPARTMENT OFMMH2025-11-26
00810142372039SoftBankSCC SOFT COMPUTERMMH2025-10-04
00810055818310SoftID.TxSCC SOFT COMPUTERMMH2025-09-06
00860011763208NDDR and CDCSCIELOWORKS, INC.MMH2025-07-16
00860014128905MediCopiaLattice IncorporatedMMH2025-06-04
00860009119406ABO Express V 2.0.0Blood Bank Computer SystemMMH2025-04-28
00860009119420Blood Bank Control System 6.0Blood Bank Computer SystemMMH2025-04-28
00860009119437ABO Wheels V 1.0.0Blood Bank Computer SystemMMH2025-04-28
00860009119444ABO QuickPass V 1.0.0Blood Bank Computer SystemMMH2025-04-28
00860009119451BBCS BloodTrack Interface ApplicationBlood Bank Computer SystemMMH2025-04-28
00860009119468BBCS Hospital Interface ApplicationBlood Bank Computer SystemMMH2025-04-28
00860009119475Blood Bank Control System, V5.0Blood Bank Computer SystemMMH2025-04-28
00860009119482BBCS Lab Interface Application V5.0Blood Bank Computer SystemMMH2025-04-28
00867268000421bexWISE APIIT SYNERGISTICS, LLCMMH2025-04-08
00850053416002Blood Product Administration ModuleEPIC SYSTEMS CORPORATIONMMH2025-02-03
1928342896382000Donor-IDHEALTHCARE ID, INC.MMH2025-01-14
B236SQBB202410Clinisys SQ Blood BankCliniSys, IncMMH2024-12-06
10888234002475ImmuLINKIMMUCOR, INC.MMH2024-12-05
03665324000050ePROGESAMAK-SYSTEM GROUP LIMITEDMMH2024-11-27
1928342896381900Donor-IDHEALTHCARE ID, INC.MMH2024-11-14
00810142371827SoftBankSCC SOFT COMPUTERMMH2024-11-13
00860010612866SDNet Configurable Manual Batch EntryRubin & Poor, Inc.MMH2024-10-15
00857222008037Blood Bank Information Management SystemCARTER BLOODCAREMMH2024-09-09