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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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Transfer Bag 300 ml
HAEMONETICS CORPORATION
732-32M
In Commercial Distribution

  • 30887691002848 ()
  • 20887691002841 ()

  • Total Volume: 300 Milliliter


  • Blood/tissue storage/culture container
3-NCC987 SCD Wafer
TERUMO BCT, INC.
3NCC987
In Commercial Distribution

  • 55020583260318 ()
  • 35020583260314 ()
  • 05020583260313 ()


  • Package sealing unit
Persona™ Plasma Pooling Bottles
HAEMONETICS CORPORATION
0699S-12
In Commercial Distribution

  • 00812747019807 ()
  • 30812747019808 ()


  • Apheresis system tubing set
UNIT PACK ASSY,SHAKER,ACP215
HAEMONETICS CORPORATION
50042-00
In Commercial Distribution

  • 30812747015183 ()


  • Blood cell freeze/thaw system
MCS+, 220V, LN09000-220-EW-RU
HAEMONETICS CORPORATION
09000-220-EW
In Commercial Distribution

  • 30812747012878 ()


  • Apheresis system
No Description
HAEMONETICS CORPORATION
09000-220-ED
In Commercial Distribution

  • 30812747012861 ()


  • Apheresis system
MCS+, 220V ENGL, LN 09000-220-E
HAEMONETICS CORPORATION
09000-220-E
In Commercial Distribution

  • 30812747012854 ()


  • Apheresis system
MCS+ ,110V ENGL, LN 09000-110-E
HAEMONETICS CORPORATION
09000-110-E
In Commercial Distribution

  • 30812747012816 ()


  • Apheresis system
PCS2, LN, 06002-110-EXS-EW
HAEMONETICS CORPORATION
06002-110-EXS-EW
In Commercial Distribution

  • 30812747011987 ()


  • Autotransfusion system blood component processing set
PCS2, LIST NO. 06002-220-EXP-EW
HAEMONETICS CORPORATION
06002-220-EXP-EW
In Commercial Distribution

  • 30812747011963 ()


  • Autotransfusion system blood component processing set
PCS2, LIST NO. 06002-220-EXP
HAEMONETICS CORPORATION
06002-220-EXP
In Commercial Distribution

  • 30812747011956 ()


  • Autotransfusion system blood component processing set
PCS2, LIST NO. 06002-CP-220, RU
HAEMONETICS CORPORATION
06002-CP-220-RU
In Commercial Distribution

  • 30812747011840 ()


  • Autotransfusion system blood component processing set
PCS2, LIST NO, LN06002-CP-220-EW
HAEMONETICS CORPORATION
06002-CP-220-EW
In Commercial Distribution

  • 30812747011833 ()


  • Autotransfusion system blood component processing set
PCS2, LIST NO. 06002-CP-220
HAEMONETICS CORPORATION
06002-CP-220
In Commercial Distribution

  • 30812747011826 ()


  • Autotransfusion system blood component processing set
PCS2,LIST NO,LN06002-110-NA-EW
HAEMONETICS CORPORATION
06002-110-NA-EW
In Commercial Distribution

  • 30812747011819 ()


  • Autotransfusion system blood component processing set
Plasma Bottles with Saline Adapter
HAEMONETICS CORPORATION
0694S-00
In Commercial Distribution

  • 30812747011673 ()
  • 00812747011672 ()

  • Total Volume: 1000 Milliliter


  • Apheresis system tubing set
No Description
SCC SOFT COMPUTER
25.6.1.1
In Commercial Distribution

  • 00810055812837 ()


  • 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
25.5.6.2
In Commercial Distribution

  • 00810055810727 ()


  • Blood bank information system application software
SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
ITL ASIA PACIFIC SDN. BHD.
A200200
Not in Commercial Distribution

  • 19555240401349 ()
  • 19555240401332 ()
  • 19555240401356 ()
A200200

  • Blood donor bag segment sampling IVD
DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100150
In Commercial Distribution

  • 09555240400154 ()
  • 19555240400151 ()
A100150

  • Needle guard
DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100100
In Commercial Distribution

  • 09555240400130 ()
  • 19555240400137 ()
A100100

  • Needle guard
HemoCue Plasma/Low Hb Photometer mg/dL
Hemocue AB
120314
In Commercial Distribution

  • 07311091203144 ()
120314

  • Haemoglobin analyser IVD, point-of-care
3M™ Ranger® Fluid Warming Set, Standard Flow, 10 Per Case 24110
3M COMPANY
24110
In Commercial Distribution

  • 50608223241108 ()
  • 00608223241103 ()
24110

  • Conduction blood/fluid warmer set
3M™ Ranger™ Hose Cap, 12 per Case, 90026
3M COMPANY
90026
In Commercial Distribution

  • 50707387781922 ()
  • 00707387781927 ()
90026

  • Conduction blood/fluid warmer set
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
Red Blood Cell Diluent for TANGO instruments, 10x10 ml
Bio-Rad Medical Diagnostics GmbH
806210100
In Commercial Distribution

  • 07611969951307 ()
806210100

  • Bromelin immunohaematology reagent 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
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
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
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
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