WellSky Blood Centers

GUDID B105BLOODCENTERS2019

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

WELLSKY CORPORATION

Blood bank information system application software
Primary Device IDB105BLOODCENTERS2019
NIH Device Record Keyd31b231c-6352-4a20-af47-20ab705b7ff4
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellSky Blood Centers
Version Model Number2019
Company DUNS177240249
Company NameWELLSKY CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB105BLOODCENTERS2019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MMHBlood Establishment Computer Software And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-06
Device Publish Date2019-05-09

On-Brand Devices [WellSky Blood Centers]

B105BLOODCENTERS2019Blood Centers is a comprehensive, modular, computerized system intended to be used by trained p
B105BLOODCENTERS0Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe
B105BLOODCENTERS2023Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe
B105BLOODCENTERS2018Blood Centers is a comprehensive, modular, computerized system intended to be used by trained pe

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