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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ACCURUN 305 Series 100 HCV RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0080
In Commercial Distribution

  • 00816784020512 ()
2020-0080

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 305 Series 150 HCV RNA Positive Control 10 x 1.2 mL
Lgc Clinical Diagnostics, Inc.
2020-0078
In Commercial Distribution

  • 00816784020505 ()
2020-0078

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0093
In Commercial Distribution

  • 00816784020475 ()

  • Total Volume: 6 Milliliter
2015-0093

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0092
In Commercial Distribution

  • 00816784020468 ()

  • Total Volume: 42 Milliliter
2015-0092

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 155 Series 2000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0090
In Commercial Distribution

  • 00816784020451 ()
2015-0090

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 145 CMV IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0087
In Commercial Distribution

  • 00816784020437 ()
2015-0087

  • Cytomegalovirus (CMV) antigen IVD, control
ACCURUN 106 Series 1000 HIV-1 Ag 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0066
In Commercial Distribution

  • 00816784020260 ()
2015-0066

  • HIV1 antigen IVD, control
ACCURUN 106 Series 1000 HIV-1 Ag 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0065
In Commercial Distribution

  • 00816784020253 ()
2015-0065

  • HIV1 antigen IVD, control
ACCURUN 1 Multi-Marker Negative Control 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2010-0015
In Commercial Distribution

  • 00816784020222 ()

  • Total Volume: 42 Milliliter
2010-0015

  • Negative control immunoglobulin IVD
ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2010-0013
In Commercial Distribution

  • 00816784020215 ()

  • Total Volume: 5 Milliliter
2010-0013

  • Negative control immunoglobulin IVD
ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0032
In Commercial Distribution

  • 00816784020123 ()
2000-0032

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5600 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0018
In Commercial Distribution

  • 00816784020062 ()
2000-0018

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 4400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0010
In Commercial Distribution

  • 00816784020055 ()
2000-0010

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 4000 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0008
In Commercial Distribution

  • 00816784020048 ()
2000-0008

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2500 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0002
In Commercial Distribution

  • 00816784020031 ()
2000-0002

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0001
In Commercial Distribution

  • 00816784020024 ()
2000-0001

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2700 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0005
In Commercial Distribution

  • 00816784020871 ()
2000-0005

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 315 Series 500 HIV-1 RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0093
In Commercial Distribution

  • 00816784020802 ()
2020-0093

  • HIV1 nucleic acid IVD, control
ACCURUN 1 Series 8100 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0022
In Commercial Distribution

  • 00816784020789 ()
2000-0022

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5100 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0017
In Commercial Distribution

  • 00816784020772 ()

  • Total Volume: 42 Milliliter
2000-0017

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5100 Multi-Marker Positive Control 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0016
In Commercial Distribution

  • 00816784020765 ()

  • Total Volume: 15 Milliliter
2000-0016

  • Multiple blood-borne virus antigen/antibody IVD, control
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
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
ART PRP 2-Step Processing Kit
Celling Biosciences
1651-0001
In Commercial Distribution

  • 00817771029983 ()
1651-0001

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP 2-Step Device with SightWheel
Celling Biosciences
1601W-0001
In Commercial Distribution

  • 00817771029525 ()
1601W-0001

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP 2-Step Device
Celling Biosciences
1601-0001
In Commercial Distribution

  • 00817771029174 ()
1601-0001

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP 2-Step - this is a duplicate. see 1601-0001 - UDI# 00817771029174
Celling Biosciences
1601-0001
Not in Commercial Distribution

  • 00817771028887 ()
Duplicate See 000817771029174

  • Haematological concentrate system preparation kit, platelet concentration
ART GFC Kit
Celling Biosciences
0887-0001
In Commercial Distribution

  • 00817771027613 ()
0887-0001

  • Bone graft syringe, single-use
ART PRP Plus Processing Kit
Celling Biosciences
0885-2000
In Commercial Distribution

  • 00817771027569 ()
0885-2000

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP PLus Processing Kit
Celling Biosciences
0885-1060
In Commercial Distribution

  • 00817771027552 ()
0885-1060

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP Processing Kit
Celling Biosciences
0885-1000
In Commercial Distribution

  • 00817771027545 ()
0885-1000

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP Processing Kit
Celling Biosciences
0885-0060
In Commercial Distribution

  • 00817771027538 ()
0885-0060

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP Plus Device
Celling Biosciences
0865-0002
In Commercial Distribution

  • 00817771027507 ()
0865-0002

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP Device
Celling Biosciences
0885-0001
In Commercial Distribution

  • 00817771027491 ()
0885-0001

  • Haematological concentrate system preparation kit, platelet concentration
120cc: Graft Delivery Kit
Celling Biosciences
0852-0120
In Commercial Distribution

  • 00817771027392 ()
0852-0120

  • Bone graft syringe, single-use
Graft Delivery Kit
Celling Biosciences
0852-0001
In Commercial Distribution

  • 00817771027385 ()
0852-0001

  • Bone graft syringe, single-use
Blood Draw Kit
Celling Biosciences
0851-3060
In Commercial Distribution

  • 00817771027378 ()
0851-3060

  • Bone graft syringe, single-use
Small Volume Bone Marrow Aspiration Kit
Celling Biosciences
0851-1070
In Commercial Distribution

  • 00817771027361 ()
0851-1070

  • Bone graft syringe, single-use
Bone Marrow Aspiration Kit
Celling Biosciences
0851-1060
In Commercial Distribution

  • 00817771027354 ()
0851-1060

  • Bone graft syringe, single-use
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