FDA.reportPublic FDA data

SoftBank

Primary DI
00810142372992
Brand
SoftBank
Company
SCC SOFT COMPUTER
Model
25.6.4.0
Published
2026-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
BK2005310

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2005310

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810142372992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810142372992008101423729928101423729920810142372992

Regulatory Flags#

DUNS number
131311409
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810142374668SoftBiochemistry4.4.0.02026-10-28
00810142374675SoftCytogenetics4.4.0.02026-10-28
00810142374682SoftPathDx4.4.0.02026-10-28
00810142374699SoftFlowCytometry4.4.0.02026-10-28
00810142374705SoftHLA4.4.0.02026-10-28
00810142374712SoftMolecular4.4.0.02026-10-28
00810142374729SoftGenomics4.4.0.02026-10-28
00810142374736SoftTrack4.4.0.02026-10-28
00810142374941SoftBiochemistry4.3.0.62026-10-16
00810142374958SoftCytogenetics4.3.0.62026-10-16
00810142374965SoftPathDx4.3.0.62026-10-16
00810142374972SoftFlowCytometry4.3.0.62026-10-16
00810142374989SoftHLA4.3.0.62026-10-16
00810142374996SoftMolecular4.3.0.62026-10-16
00810142375009SoftGenomics4.3.0.62026-10-16
00810142375016SoftTrack4.3.0.62026-10-16
00810142374071SoftTotalQC1.0.13.02026-10-07
00810142373456SoftLab4.5.8.122026-09-29
00810142373463SoftMic4.5.8.122026-09-29
00810142374378SoftBiochemistry4.3.0.42026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010651216Blood Product Questionnaire ModuleBUOY SOFTWARE, LLCMMH2026-07-24
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