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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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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
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 07290110123055 ()
AAVF16042301

  • Liposuction system
The Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Determine™ HIV-1/2 Ag/Ab Combo Assay only.
Alere Scarborough, Inc.
7D2628
In Commercial Distribution

  • 00811877011125 ()


  • HIV1/HIV2 antigen/antibody IVD, control
Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
In Commercial Distribution

  • 00811877011101 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical
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
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