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Sepacell PLD-10ALeukocyte Reduction Y-Administration Set.
Sterile Fluid Path
FENWAL, INC.
4C4502
In Commercial Distribution
- 10811137010438 ()
- 00811137010431 ()
4C4502
- Blood transfusion set, non-exchange
For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use With the ALYX™ System.
Sterile Fluid Path.
FENWAL, INC.
4R5700
In Commercial Distribution
- 00811137010134 ()
- 10811137010131 ()
4R5700
- Apheresis system tubing set
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 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
(bidirectional) WellSky Transfusion 2024 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
2024
In Commercial Distribution
- B105TRANSFUSION20240 ()
- Blood bank information system application software
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
In Commercial Distribution
- B105TRANSFUSION2021 ()
- Blood bank information system application software
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
2020
In Commercial Distribution
- B105TRANSFUSION2020 ()
- Blood bank information system application software
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
In Commercial Distribution
- B105TRANSFUSION20190 ()
- Blood bank information system application software
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
In Commercial Distribution
- B105TRANSFUSION20180 ()
- Blood bank information system application software
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 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 (bidirectional)
WellSky Transfusion 2022 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
2022
In Commercial Distribution
- B105TRANSFUSION0 ()
- Blood bank information system application software
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
2012
In Commercial Distribution
- B105LIFETRAK0 ()
- Blood bank information system application software
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 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 (bidirectional)
HCLL 2015R2 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
2015R2
In Commercial Distribution
- B105HCLL0 ()
- 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
2023
In Commercial Distribution
- B105BLOODCENTERS2023 ()
- 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
2019
In Commercial Distribution
- B105BLOODCENTERS2019 ()
- 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
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
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
Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823300
Not in Commercial Distribution
- 07611969952939 ()
823300
- HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
Red Blood Cell Diluent for TANGO instruments, 10x10 mL
Bio-Rad Medical Diagnostics GmbH
806210100
In Commercial Distribution
- 07611969965755 ()
806210100
- Bromelin immunohaematology reagent IVD
Gel card for use with the IH system; Card for antibody detection of human red blood cells; 288 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813612100
In Commercial Distribution
- 07611969964871 ()
813612100
- ABO/Rh multiple blood grouping IVD, kit, agglutination
Gel card for use with the IH system; Card for antibody detection of human red blood cells; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813610100
In Commercial Distribution
- 07611969964864 ()
813610100
- ABO/Rh multiple blood grouping IVD, kit, agglutination
Instrument
Bio-Rad Medical Diagnostics GmbH
848900010
In Commercial Distribution
- 07611969961696 ()
848900010
- Immunohaematology/blood bank analyser IVD
IgG-coated red blood cells for the control of antiglobulin test; 10ml
Bio-Rad Medical Diagnostics GmbH
816030100
In Commercial Distribution
- 07611969952502 ()
816030100
- Immunoglobulin-sensitized reagent red blood cell IVD, control
For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3x3 mL sera (human, polyclonal)
Bio-Rad Medical Diagnostics GmbH
814172100
In Commercial Distribution
- 07611969952342 ()
- Multiple immunohaematology test IVD, control
Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing for use with the IH-System
Bio-Rad Medical Diagnostics GmbH
814171100
In Commercial Distribution
- 07611969952335 ()
- Multiple immunohaematology test IVD, control
Gel card for use with the IH system; Card for antibody detection of human red blood cells; 48 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813611100
In Commercial Distribution
- 07611969952229 ()
813611100
- ABO/Rh multiple blood grouping IVD, kit, agglutination
Optional card for the negative control in ABO and Rh typing; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813600100
In Commercial Distribution
- 07611969952212 ()
813600100
- Antisera matrix (non-reactive) IVD, control
Microplate for use in detection of red blood cell antibodies and antigens in indirect and direct antiglobulin tests with solid phase antiglobulin technique on TANGO instruments; 10 plates
Bio-Rad Medical Diagnostics GmbH
806521100
In Commercial Distribution
- 07611969951499 ()
806521100
- Solid-phase red blood cell adherence antibody/antigen IVD
Positive Control for Solidscreen II on TANGO instruments; 4ml
Bio-Rad Medical Diagnostics GmbH
806519100
In Commercial Distribution
- 07611969951468 ()
806519100
- Anti-Rh(D) antibody screen IVD, control
Positive Control for Solidscreen II on TANGO instruments; 4 ml
Bio-Rad Medical Diagnostics GmbH
806514100
In Commercial Distribution
- 07611969951390 ()
806514100
- Anti-Rh(D) antibody screen IVD, control
Negative Control for Solidscreen II on TANGO instruments; 4 ml
Bio-Rad Medical Diagnostics GmbH
806509100
In Commercial Distribution
- 07611969951352 ()
806509100
- Anti-Rh(D) antibody screen IVD, control
Red Blood Cell Diluent for TANGO instruments, 10x10 ml
Bio-Rad Medical Diagnostics GmbH
806210100
In Commercial Distribution
- 07611969951307 ()
806210100
- Bromelin immunohaematology reagent IVD
Reagent for the negative control in ABO and RH typing with Seraclone ABO and Rh reagent for tube test; 10 ml
Bio-Rad Medical Diagnostics GmbH
805171100
In Commercial Distribution
- 07611969950874 ()
805171100
- Antisera matrix (non-reactive) IVD, control
No Description
Bio-Rad Medical Diagnostics GmbH
009303
In Commercial Distribution
- 07611969226344 ()
- Test tube heater
IH-Centrifuge L for centrifugation of IH-System gel cards and/or test tubes.
Bio-Rad Medical Diagnostics GmbH
009301
In Commercial Distribution
- 07611969226320 ()
- General-purpose centrifuge IVD
No Description
SCC SOFT COMPUTER
25.6.2.0
In Commercial Distribution
- 00810142371827 ()
- Blood bank information system application software
No Description
Citra Labs, LLC
PN-7212
In Commercial Distribution
- 00887868260285 ()
- 70887868260284 ()
PN-7212
- Blood transfer set
Transfusion Manager is a comprehensive software application intended for use by trained healthcare professionals responsible for transfusion services. Transfusion Manager helps users manage the following transfusion service activities:
• Positively identify transfusion recipients
• Match blood products to recipients
• Record recipient pertinent transfusion information
• Record recipient transfusion reactions and caregiver comments
CliniSys, Inc
3.0
Not in Commercial Distribution
- B236TRM3000 ()
- 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
2024.1
In Commercial Distribution
- B236SQBB202410 ()
- 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
11.0.3
In Commercial Distribution
- B236SQBB11030 ()
- 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