FDA.reportPublic FDA data

WellSky Corporation. - Headquarters

Matched from indexed company URL: WELLSKY CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30061293913006129391WellSky Corporation. - Headquarters1N2026-01-0111300 Switzer Road -- Overland Park KS US 66210

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submission
947161485809132BK230826
947161772715963BK200479
947161481011865BK180200
947161382502037BK160066
947161549549643BK120039
947161021068495BK120036
947161435579085BK100069
947161579859456BK100057
947161192766196BK100043
947161652216146BK060019
947161660118780BK050011
947161176209561BK030078
947161175385743BK010052

PMN#

GUDID#

WellSky Transfusion - WellSky Transfusion is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.WellSky Transfusion is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device(bidirectional) WellSky Transfusion provides customized control processes for transfusion management of all proceduresand testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WELLSKY CORPORATION

2026-01-14

WellSky Blood Centers - 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

2024-05-31

WellSky Transfusion - WellSky Transfusion 2024 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.WellSky Transfusion 2024 is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device(bidirectional) WellSky Transfusion 2024 provides customized control processes for transfusion management of all proceduresand testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WELLSKY CORPORATION

2023-12-14

WellSky Transfusion - WellSky Transfusion 2023 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.WellSky Transfusion 2023 is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device(bidirectional) WellSky Transfusion 2023 provides customized control processes for transfusion management of all proceduresand testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WELLSKY CORPORATION

2023-12-06

WellSky Blood Centers - 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

2023-06-12

HCLL - HCLL 2015R2 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.HCLL 2015R2 is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)HCLL 2015R2 provides customized control processes for transfusion management of all procedures andtesting on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WELLSKY CORPORATION

2023-06-12

LifeTrak - LifeTrak 2012 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

2023-06-12

WellSky Blood Centers - 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

2023-05-12

WellSky Blood Centers - 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

2022-02-10

WellSky Transfusion - WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.WellSky Transfusion 2022 is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)WellSky Transfusion 2022 provides customized control processes for transfusion management of all procedures andtesting on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WELLSKY CORPORATION

2022-02-10

WellSky Transfusion - WellSky Tranfusion 2020 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2020 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage device (bi-directional)WellSky Transfusion 2020 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WELLSKY CORPORATION

2021-02-09

WellSky Transfusion - WellSky Transfusion 2021 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2021 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage device (bi-directional)WellSky Transfusion 2021 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WELLSKY CORPORATION

2021-02-09

WellSky Blood - Emergency Issue - WellSky™ Blood – Emergency Issue 2020 R1 is a Blood Establishment Computer Software (BECS) Accessory that provides the ability to perform an Emergency Issue. WellSky Blood – Emergency Issue provides customized control processes for Emergency Issue management to reduce human error and enhance the ability to assure patient product safety. Functionality is provided for patient identification, support of emergency patient safety protocols, issue blood products under emergency conditions and confirmation scan of correct transfusion slip on correct unit. WellSky™ Blood – Emergency Issue 2020 R1 can be used to emergency issue products on a mobile device and desktop workstation.WellSky™ Blood – Emergency Issue 2020 R1 is not a standalone system. WellSky™ Blood Emergency Issue 2020 depends on HCLL™ Transfusion to obtain patient data, as well as to send unit information, safety data, and regulatory inspection step data back to HCLL™ Transfusion. will communicate bi-directionally through intelligent integration messages to obtain patient information and to update and record the Emergency Issue in HCLL™ Transfusion. HCLL™ Transfusion stores this information in the Transfusion database, exactly now Transfusion processes and stored this data currently. WellSky Blood Emergency Issue does not maintain data.

WELLSKY CORPORATION

2020-06-15

WellSky Transfusion - WellSky Tranfusion 2019 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2015 R2 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage device (bi-directional)WellSky Transfusion 2018 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WELLSKY CORPORATION

2019-09-19

WellSky Blood Centers - 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

2019-05-09

WellSky Transfusion - WellSky™ Transfusion 2018 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling, there is no hardware or other components included in the final product. WellSky™ Transfusion 2018 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage devices (bi-directional)WellSky™ Transfusion 2018 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety

WELLSKY CORPORATION

2018-09-14