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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
2018
In Commercial Distribution
- B105BLOODCENTERS2018 ()
- Blood bank information system application software
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
In Commercial Distribution
- B105BLOODCENTERS0 ()
- Blood bank information system application software
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
In Commercial Distribution
- B105BLOOD2020 ()
- Blood bank information system application software
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
In Commercial Distribution
- B10520241 ()
- Blood bank information system application software
Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
900
In Commercial Distribution
- B180IMB029000 ()
IMB02900
- Clinical laboratory information system application software
Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
817
In Commercial Distribution
- B180IMB028170 ()
IMB02817
- Clinical laboratory information system application software
Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
816
In Commercial Distribution
- B180IMB028160 ()
IMB02816
- Clinical laboratory information system application software
Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
8150011
Not in Commercial Distribution
- B180IMB028150 ()
IMB02815
- Clinical laboratory information system application software
Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
8141101
Not in Commercial Distribution
- B180IMB028140 ()
IMB02814
- Clinical laboratory information system application software
Sunquest Blood Bank System
CliniSys, Inc
8.3.x
Not in Commercial Distribution
- B236LABBB830 ()
- Blood bank information system application software
Sunquest Blood Bank System
CliniSys, Inc
8.2.2
Not in Commercial Distribution
- B236LABBB8220 ()
- Blood bank information system application software
Sunquest Blood Bank System
CliniSys, Inc
8.2.1
Not in Commercial Distribution
- B236LABBB8210 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
8.2.3
Not in Commercial Distribution
- B236BB8230 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
8.1.3
Not in Commercial Distribution
- B236BB8130 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
8.0.1
Not in Commercial Distribution
- B236BB8010 ()
- Blood bank information system application software
Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.2
Not in Commercial Distribution
- B236BB11020 ()
- Blood bank information system application software
Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.1
Not in Commercial Distribution
- B236BB11010 ()
- Blood bank information system application software
Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0
Not in Commercial Distribution
- B236BB11000 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.1.1
Not in Commercial Distribution
- B236BB10110 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.1
Not in Commercial Distribution
- B236BB10100 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.0.1
Not in Commercial Distribution
- B236BB10010 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.0
Not in Commercial Distribution
- B236BB10000 ()
- Blood bank information system application software
NDDR version 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution
- 00812747010217 ()
- Clinical laboratory information system application software
Donor Doc version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution
- 00812747010200 ()
- Configurable electronic form web-based application software
Symphony version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution
- 00812747010194 ()
- Blood bank information system application software
NexLynk DMS version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution
- 00812747010187 ()
- Blood bank information system application software
Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution
- 00812747010170 ()
- Blood bank information system application software
McKesson Blood Bank version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution
- 00812747010118 ()
- Blood bank information system application software
SafeTrace Tx version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution
- 00812747010101 ()
- Blood bank information system application software
CDCS version 1.x.x
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution
- 00812747010064 ()
- Clinical laboratory information system application software
SafeTrace Tx version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution
- 00812747010033 ()
- Blood bank information system application software
BloodSafe version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution
- 00812747010019 ()
- Clinical laboratory information system application software
BloodTrack version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution
- 00812747010002 ()
- Clinical laboratory information system application software
Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product information DVD, tonometer, power cord/adapter, BP cuffs, and others).
CONFIGURATIONS ENCOMPASSED BY THE XCEL VERSION/MODEL:
• XCEL-PWA Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only].
• XCEL-PWV Configuration: [SphygmoCor software configured for pulse wave velocity (PWV) only].
• XCEL-PWA+PWV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)].
ATCOR MEDICAL PTY LTD
XCEL
In Commercial Distribution
- 19351315000031 ()
- 19351315000048 ()
- Patient monitoring system module, multifunction
No Description
HEALTHCARE ID, INC.
3.3.5
In Commercial Distribution
- 1928342896382000 ()
- Configurable electronic form web-based application software
Donor-ID 3.3.4.0
HEALTHCARE ID, INC.
3.3.4.0
In Commercial Distribution
- 1928342896381900 ()
- Configurable electronic form web-based application software
A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC W MDR E
In Commercial Distribution
- 04547410556452 ()
- Stationary basic diagnostic x-ray system, digital
A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC MDR E
In Commercial Distribution
- 04547410556438 ()
- Stationary basic diagnostic x-ray system, digital
A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC W E
In Commercial Distribution
- 04547410307061 ()
- Stationary basic diagnostic x-ray system, digital
A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC E
In Commercial Distribution
- 04547410306651 ()
- Stationary basic diagnostic x-ray system, digital