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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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REAL INTELLIGENCE FOOT PEDAL
Smith & Nephew, Inc.
ROB10026
In Commercial Distribution

  • 00885556757444 ()
ROB10026

  • Robotic surgical arm system
REAL INTELLIGENCE TRACKING CAMERA
Smith & Nephew, Inc.
ROB10025
In Commercial Distribution

  • 00885556757437 ()
ROB10025

  • Robotic surgical arm system
Real Intelligence Cori
Smith & Nephew, Inc.
ROB10024
In Commercial Distribution

  • 00885556757420 ()
ROB10024

  • Robotic surgical arm system
CORI Starter Kit
Smith & Nephew, Inc.
ROB10000
In Commercial Distribution

  • 00885556755068 ()
ROB10000

  • Robotic surgical arm system
RI.HIP NAVIGATION CORI SERVICE KIT
Smith & Nephew, Inc.
ROB20024
In Commercial Distribution

  • 00885556806609 ()
ROB20024

  • Robotic surgical arm system
RI.HIP NAVIGATION CORI USA LATAM APAC BUNDLE
Smith & Nephew, Inc.
ROB20018
In Commercial Distribution

  • 00885556806548 ()
ROB20018

  • Robotic surgical arm system
Navio Surgical System Refurbished US
Smith & Nephew, Inc.
NPFS02000F
In Commercial Distribution

  • 00885556628744 ()
NPFS02000F

  • Robotic surgical arm system
Navio BBT Footpedal
Smith & Nephew, Inc.
PFSR120031
In Commercial Distribution

  • 00885556628485 ()
PFSR120031

  • Robotic surgical arm system
Navio Camera Cart
Smith & Nephew, Inc.
PFSR110001
In Commercial Distribution

  • 00885556628461 ()
PFSR110001

  • Robotic surgical arm system
Navio Surgical System US
Smith & Nephew, Inc.
NPFS02000
In Commercial Distribution

  • 00885556628416 ()
NPFS02000

  • Robotic surgical arm system
REAL INTELLIGENCE Implant Database
Smith & Nephew, Inc.
ROB10400
In Commercial Distribution

  • 00885556775547 ()
ROB10400

  • Robotic surgical arm system
No Description
Hologic, Inc.
Cervista HTA System Computer
Not in Commercial Distribution

  • 15420045501065 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
Cervista Manual System Computer
Not in Commercial Distribution

  • 15420045501058 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
The Liberty SRIMPORT software is an interface that is part of the SRIMPORT functionality to import data through a file based transmission. Its intended use is to import results from laboratory instruments, typically chemistry and special chemistry analysers. The interface module contains no interpretation algorithms and serves as a library functions to consolidate pre-determined results from external instruments. The Liberty SRIMPORT Software's indicated use is in the Blood Bank, Donor Centre and Plasma Testing Laboratories as well as Clinical Diagnostic and Screening Laboratories. It may be applied to a group of laboratory instruments that export test results to another device.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.1
In Commercial Distribution

  • 05060496770059 ()


  • Blood bank information system application software
Sanguin Aurora 2.0 is indicated for use in Clinical Diagnostic Laboratories, Blood Bank and Blood Establishments where it captures test and result data from laboratory equipment. It can be applied to single tests or a panel of tests that are used to screen blood donation (whole blood or plasma) as a pre-requisite to transfusion. Typically these tests would include markers such as Hepatitis Markers and HIV and may include non-viral testing such as ABO and Rhesus confirmation of donors, patient typing and antibody screening.
BIOMEDICAL DATA SOLUTIONS LIMITED
2.0
In Commercial Distribution

  • 05060496770035 ()


  • Blood bank information system application software
Software, blood bank, stand alone product
CIRDAN IMAGING LIMITED
4.1
In Commercial Distribution

  • 05060508820031 ()


  • Blood bank information system application software
No Description
EPIC SYSTEMS CORPORATION
4
In Commercial Distribution

  • 00850053416002 ()


  • Blood bank information system application software
HemoSphere Roll Stand
Edwards Lifesciences LLC
HEMRLSTD1000
In Commercial Distribution

  • 00690103197105 ()

  • Height: 1118 mm
HEMRLSTD1000

  • Transportable medical equipment stand, non-powered
No Description
EPIC SYSTEMS CORPORATION
2
In Commercial Distribution

  • 00860475000345 ()


  • Blood bank information system application software
No Description
EPIC SYSTEMS CORPORATION
3
In Commercial Distribution

  • 00860475000314 ()


  • Blood bank information system application software
BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility processing for blood donors. It is used for manufacturing blood products and for shipping those products to customer hospitals for eventual transfusion.
CARTER BLOODCARE
v3.01
In Commercial Distribution

  • 00857222008037 ()


  • Blood bank information system application software
iWeBB electronic Laboratory Information System (iWeBB- eLIS), also referred to as eLIS, is software for managing patient transfusion requirements, patients’ blood specimen tests, and patient laboratory results. eLIS provides the blood bank laboratory with: * Patient management * Request order management * Patient testing management * Product order and fulfillment management including an interface to the blood center’s product inventory * Computer crossmatch and manual crossmatch data management * Interfaces to laboratory instruments. Trained laboratory personnel use eLIS to record patient information, manage specimens, enter single and batch test orders, and maintain test results. In concert with inventory control modules in other blood establishment computer software, eLIS can be used to complete cross match of a patient’s requirements with products in inventory, manage blood orders and maintain product data related to patient transfusions.
CARTER BLOODCARE
1.0
In Commercial Distribution

  • 00857222008013 ()


  • Blood bank information system application software
BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility processing for blood donors. It is used for manufacturing blood products and for shipping those products to customer hospitals for eventual transfusion.
CARTER BLOODCARE
2.06
In Commercial Distribution

  • 00857222008006 ()


  • Blood bank information system application software
e-Delphyn LIS 21.x.x (US)
Gpi Usa, Inc.
21.x.x (US)
In Commercial Distribution

  • 00860007282744 ()


  • Blood bank information system
Surround 5.x
Gpi Usa, Inc.
5.x
In Commercial Distribution



  • Blood bank information system
Donor Doc 3.x.x
Gpi Usa, Inc.
3.x.x
In Commercial Distribution



  • Configurable electronic form web-based application software
ElDorado Donor 3.x.x
Gpi Usa, Inc.
3.x.x
In Commercial Distribution



  • Blood bank information system
e-Delphyn Donor version 11.x.x (US)
Gpi Usa, Inc.
11(US)
In Commercial Distribution

  • 00860007282706 ()


  • Blood bank information system
Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.
ARC-ONE SOLUTIONS, LLC
2.0.0.0
In Commercial Distribution

  • 00860006793708 ()
2.0.0.0

  • Blood bank information system application software
NDDR and CDCS is a web-based application that is intended to meet the needs of participating donation centers to check for the presence of recent blood or blood components (including plasma) donations at other donation centers by a prospective donor, as well as check if prospective donors have been deferred by participating donation centers.
CIELOWORKS, INC.
2.3
In Commercial Distribution

  • 00860011763208 ()


  • Blood bank information system application software
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