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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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No Description
EMCYTE CORP.
620-22-09
In Commercial Distribution

  • 00855306003329 ()
620-22-09

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration
No Description
EMCYTE CORP.
620-22-07
In Commercial Distribution

  • 00855306003305 ()
620-22-07

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration
No Description
EMCYTE CORP.
GS30
In Commercial Distribution

  • 00855306003190 ()
GS30

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
GS60-PURE
In Commercial Distribution

  • 00855306003183 ()
GS60-PURE

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
GS120
In Commercial Distribution

  • 00855306003084 ()
GS120

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration
No Description
EMCYTE CORP.
620-11-08
In Commercial Distribution

  • 00855306003046 ()
620-11-08

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
The bexWISE API (v1.0) is for use in blood establishments to facilitate communication between 510(k) cleared Blood Establishment Computer Systems (BECS), allowing the exchange of donor and donation-related data used to determine donor eligibility and donation suitability.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution

  • 00867268000421 ()


  • Blood bank information system application software
The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and blood components, which blood establishments rely on for making decisions regarding the release of blood components for transfusion or further manufacturing. Specifically, laboratory testing, product manufacturing and inventory control/distribution.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution

  • 00867268000414 ()


  • Blood bank information system application software
The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection process. The system identifies results and responses throughout the process that can be considered ‘high-risk’ to the general blood supply which notifies and allows a staff member to complete a review to determine donor suitability. The DoVac Elite application is capable of capturing all information in the collection process: registration, physical exam, computer assisted medical questionnaire, donor consent, donation identification number assignment, phlebotomy, supervisor review and audit. The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions.
IT SYNERGISTICS, LLC
2.0
In Commercial Distribution

  • 00867268000407 ()


  • Blood bank information system application software
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of  human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the  Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution

  • 00866489000036 ()
740769

  • Pipetting system
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