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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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Broadband Modem
Respironics, Inc.
Broadband Modem
In Commercial Distribution

  • 00606959033221 ()
1079794

  • Clinical laboratory information system
Oximetry Accessory, EU
Respironics, Inc.
Oximetry Accessory, EU
Not in Commercial Distribution

  • 00606959028616 ()
100245E

  • Clinical laboratory information system
Broadband Modem RoHS, EU
Respironics, Inc.
Broadband Modem, RoHS, EU
Not in Commercial Distribution

  • 00606959028241 ()
1125388

  • Clinical laboratory information system
Broadband Modem Ethernet Adapter
Respironics, Inc.
Broadband Ethernet Adapter
In Commercial Distribution

  • 00606959028234 ()
1079885

  • Clinical laboratory information system
Broadband Oximetry Accessory, Japan
Respironics, Inc.
Broadband/Oximetry Accessory, JP
Not in Commercial Distribution

  • 00606959028197 ()
100225E

  • Clinical laboratory information system
Broadband Oximetry Accessory, USA
Respironics, Inc.
Broadband/Oximetry Accessory, US
Not in Commercial Distribution

  • 00606959028180 ()
100205E

  • Clinical laboratory information system
Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories.
Wallac Oy
5002-0180
In Commercial Distribution

  • 06438147153312 ()
5002-0180

  • Clinical laboratory information system
Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.
Wallac Oy
5002-0130
In Commercial Distribution

  • 06438147153275 ()
5002-0130

  • Clinical laboratory information system
The Evoya Software Platform is an in vitro diagnostics modular software intended to be used together with Neonatal screening assay systems to enable workflow activities, data management, results analysis and reporting. The EVOYA Software Platform is intended to be used by trained laboratory professionals. The Evoya Software Platform is intended for in vitro diagnostic use.
Wallac Oy
5021-1000
In Commercial Distribution

  • 06438147366804 ()
5021-1000

  • Clinical laboratory information system
The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data.
Wallac Oy
5002-0540
In Commercial Distribution

  • 06438147352401 ()
5002-0540

  • Clinical laboratory information system
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