WellSky Blood Centers - Blood Centers is a comprehensive, modular, - WELLSKY CORPORATION

Duns Number:177240249

Device Description: Blood Centers is a comprehensive, modular, computerized system intended to be used by trai 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

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More Product Details

Catalog Number

-

Brand Name

WellSky Blood Centers

Version/Model Number

2022

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK180200

Product Code Details

Product Code

MMH

Product Code Name

Blood Establishment Computer Software And Accessories

Device Record Status

Public Device Record Key

be6a377e-ed8e-44b8-91b9-b79e8970f97c

Public Version Date

February 18, 2022

Public Version Number

1

DI Record Publish Date

February 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELLSKY CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8