WellSky Blood Centers

Primary DI
B10520241
Brand
WellSky Blood Centers
Company
WELLSKY CORPORATION
Model
2024
Device description
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
Published
2024-05-31
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
BK1802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1802000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B10520241PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
177240249
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B105TRANSFUSION20250WellSky Transfusion20252026-01-14
B105TRANSFUSION20240WellSky Transfusion20242023-12-14
B105TRANSFUSION2023WellSky Transfusion20232023-12-06
B105BLOODCENTERS2018WellSky Blood Centers20182023-06-12
B105HCLL0HCLL2015R22023-06-12
B105LIFETRAK0LifeTrak20122023-06-12
B105BLOODCENTERS2023WellSky Blood Centers20232023-05-12
B105BLOODCENTERS0WellSky Blood Centers20222022-02-10
B105TRANSFUSION0WellSky Transfusion20222022-02-10
B105TRANSFUSION2020WellSky Transfusion20202021-02-09
B105TRANSFUSION2021WellSky Transfusion20212021-02-09
B105BLOOD2020WellSky Blood - Emergency Issue20202020-06-15
B105TRANSFUSION20190WellSky Transfusion20192019-09-19
B105BLOODCENTERS2019WellSky Blood Centers20192019-05-09
B105TRANSFUSION20180WellSky Transfusion20182018-09-14

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Primary DI, Brand, Company table
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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
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00860009119451BBCS BloodTrack Interface ApplicationBlood Bank Computer SystemMMH2025-04-28
00860009119468BBCS Hospital Interface ApplicationBlood Bank Computer SystemMMH2025-04-28
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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