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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Solidscreen II Strip - 07611969951499

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

Solidscreen II-Control B - 07611969951468

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

Solidscreen II-Control - 07611969951390

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

Solidscreen II Negative Control - 07611969951352

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

Bromelin for Erytype - 07611969951307

Red Blood Cell Diluent for TANGO instruments, 10x10 ml
Bio-Rad Medical Diagnostics GmbH
806210100
In Commercial Distribution

  • 07611969951307 ()
806210100

  • Bromelin immunohaematology reagent IVD

Seraclone Control AB0+Rh - 07611969950874

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

IH-Incubator L - 07611969226344

No Description
Bio-Rad Medical Diagnostics GmbH
009303
In Commercial Distribution

  • 07611969226344 ()


  • Test tube heater

IH-Centrifuge L - 07611969226320

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

Bromelin for Erytype - 07611969965755

Red Blood Cell Diluent for TANGO instruments, 10x10 mL
Bio-Rad Medical Diagnostics GmbH
806210100
In Commercial Distribution

  • 07611969965755 ()
806210100

  • Bromelin immunohaematology reagent IVD

IH-Card Neutral - 07611969964871

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

IH-Card Neutral - 07611969964864

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

WellSky Transfusion - B105TRANSFUSION20240

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 - B105TRANSFUSION2021

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 Transfusion - B105TRANSFUSION2020

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 Transfusion - B105TRANSFUSION20190

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 - B105TRANSFUSION20180

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 - B105TRANSFUSION0

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 - B105LIFETRAK0

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 - B105HCLL0

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

WellSky Blood Centers - B105BLOODCENTERS2023

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

WellSky Blood Centers - 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
2019
In Commercial Distribution

  • B105BLOODCENTERS2019 ()


  • Blood bank information system application software

WellSky Blood Centers - B105BLOODCENTERS2018

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

WellSky Blood Centers - B105BLOODCENTERS0

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 Centers - B10520241

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

ElDorado Donor - 00812747010149

ElDorado Donor version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010149 ()


  • Blood bank information system application software

ElDorado Donor - 00812747010132

ElDorado Donor 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010132 ()


  • Blood bank information system application software

McKesson Blood Bank - 00812747010118

McKesson Blood Bank version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010118 ()


  • Blood bank information system application software

InstaMatch - 00812747010088

InstaMatch version 1.X.X
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution

  • 00812747010088 ()


  • Blood bank information system application software

CDCS (Cross Donation Check System) - 00812747010064

CDCS version 1.x.x
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution

  • 00812747010064 ()


  • Clinical laboratory information system application software

SafeTrace Tx - 00812747010033

SafeTrace Tx version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010033 ()


  • Blood bank information system application software

BloodSafe - 00812747010019

BloodSafe version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010019 ()


  • Clinical laboratory information system application software

NDDR (National Donor Deferral Registry) - 00812747010217

NDDR version 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010217 ()


  • Clinical laboratory information system application software

Donor Doc - 00812747010200

Donor Doc version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010200 ()


  • Configurable electronic form web-based application software

Symphony - 00812747010194

Symphony version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010194 ()


  • Blood bank information system application software

Surround - 00812747010170

Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution

  • 00812747010170 ()


  • Blood bank information system application software

NextGen - 00812747010057

NextGen version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010057 ()


  • Blood bank information system application software

Sunquest Transfusion Manager - B236TRM3000

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

Clinisys SQ Blood Bank - B236SQBB202410

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

Clinisys SQ Blood Bank - B236SQBB11030

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 - B236BB8230

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
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