FDA.reportPublic FDA data

SoftID.Tx

Primary DI
00859474006946
Brand
SoftID.Tx
Company
SCC SOFT COMPUTER
Model
1.0.0.17
Published
2021-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
BK0900780

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0900780

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859474006946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859474006946008594740069468594740069460859474006946

GMDN Terms#

Term, Definition table
TermDefinition
Bedside 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 data, within or between healthcare facilities, to support the provision and utilization of administrative and clinical information at the patient's bedside. It is typically supplied for installation into a dedicated information system used at the patient's bedside or existing mainframe or decentralized computers/networks.

Regulatory Flags#

DUNS number
131311409
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810142374064SoftBiobank1.0.1.132026-05-05
00810142373807SoftBank25.6.3.12026-04-29
00810142373975SoftBiochemistry4.3.0.22026-04-16
00810142373982SoftCytogenetics4.3.0.22026-04-16
00810142373999SoftPathDx4.3.0.22026-04-16
00810142374002SoftFlowCytometry4.3.0.22026-04-16
00810142374019SoftHLA4.3.0.22026-04-16
00810142374026SoftMolecular4.3.0.22026-04-16
00810142374033SoftGenomics4.3.0.22026-04-16
00810142374040SoftTrack4.3.0.22026-04-16
00810142373586SoftTotalQC1.0.11.12026-03-28
00810142373715SoftBiochemistry4.3.0.12026-03-12
00810142373722SoftCytogenetics4.3.0.12026-03-12
00810142373739SoftPathDx4.3.0.12026-03-12
00810142373746SoftFlowCytometry4.3.0.12026-03-12
00810142373753SoftHLA4.3.0.12026-03-12
00810142373760SoftMolecular4.3.0.12026-03-12
00810142373777SoftGenomics4.3.0.12026-03-12
00810142373784SoftTrack4.3.0.12026-03-12
00810142373340SoftTotalQC5.0.0.112026-03-11

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