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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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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
No Description
ESTAR TECHNOLOGIES LTD
1253VTSF10
Not in Commercial Distribution

  • 07290015874229 ()
1253VTSF10

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
12991402GLA
In Commercial Distribution

  • 07290015874120 ()
12991402GLA

  • Haematological concentrate system preparation kit, platelet concentration
No Description
SCC SOFT COMPUTER
25.5.6.3
In Commercial Distribution

  • 00810055813667 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.4.2
In Commercial Distribution

  • 00810055813650 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.18
In Commercial Distribution

  • 00810055812257 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.6.1.2
In Commercial Distribution

  • 00810055815647 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.20
In Commercial Distribution

  • 00810055815302 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.4
In Commercial Distribution

  • 00810055814503 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.5.1
In Commercial Distribution

  • 00810055814152 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.19
In Commercial Distribution

  • 00810055814145 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.6.1.1
In Commercial Distribution

  • 00810055812837 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.5.6.2
In Commercial Distribution

  • 00810055810727 ()


  • Blood bank information system application software
Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
STW6810-RFID
In Commercial Distribution

  • 06976052440092 ()


  • Laboratory tubing welder
Metal Wire Cassette is a disposable part of Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
Metal Wire Cassette
In Commercial Distribution

  • 16976052440068 ()
  • 06976052440061 ()


  • Laboratory tubing welder
Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
DIAGAST
210543
In Commercial Distribution

  • 23661562105438 ()
  • 13661562105431 ()
210543

  • Antisera matrix (non-reactive) IVD, control
Transfer Bag 400ml with 6 Leads
HAEMONETICS CORPORATION
732-42M
In Commercial Distribution

  • 30887691312381 ()
  • 20887691312384 ()

  • Total Volume: 400 Milliliter


  • Blood/tissue storage/culture container
Bacerial Detection System for Quality Control Testing of Platelet Products
HAEMONETICS CORPORATION
400-03
In Commercial Distribution

  • 30887691306373 ()
  • 20887691306376 ()


  • Blood collection set, invasive
Transfer Bag 1000 ml w/Y Set
HAEMONETICS CORPORATION
732-37M
In Commercial Distribution

  • 30887691002879 ()
  • 20887691002872 ()

  • Total Volume: 1000 Milliliter


  • Blood/tissue storage/culture container
Transfer Bag 300 ml
HAEMONETICS CORPORATION
732-32M
In Commercial Distribution

  • 30887691002848 ()
  • 20887691002841 ()

  • Total Volume: 300 Milliliter


  • Blood/tissue storage/culture container
No Description
ESTAR TECHNOLOGIES LTD
PPK3B
In Commercial Distribution

  • 07290015874502 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
ESTSN1650
In Commercial Distribution

  • 07290015874380 ()
ESTSN1650

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
52FF
In Commercial Distribution

  • 07290015874373 ()
52FF

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
521254US
In Commercial Distribution

  • 07290015874359 ()
521254US

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
26754E
In Commercial Distribution

  • 07290015874328 ()
26754E

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
ESTSN1690
In Commercial Distribution

  • 07290015874311 ()
ESTSN1690

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
14992905GLA
In Commercial Distribution

  • 07290015874137 ()
14992905GLA

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
12531102GLVAS
In Commercial Distribution

  • 07290015874014 ()
12531102GLVAS

  • Haematological concentrate system preparation kit, platelet concentration
Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Filter, 16-Segment Tubing, Storage Bag and Sample Pouch
HAEMONETICS CORPORATION
430-40
In Commercial Distribution

  • 30887691308742 ()
  • 20887691308745 ()


  • Blood transfusion filter
Single Collection Unit without Anticoagulant
HAEMONETICS CORPORATION
736-21
In Commercial Distribution

  • 30887691002954 ()
  • 20887691002957 ()


  • Blood collection set, invasive
Transfer Bag 600 ml w/Y set
HAEMONETICS CORPORATION
732-33M
In Commercial Distribution

  • 30887691002855 ()
  • 20887691002858 ()

  • Total Volume: 600 Milliliter


  • Blood/tissue storage/culture container
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
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