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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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ARCHITECT - 00380740157050

ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-19
Not in Commercial Distribution

  • 00380740157050 ()
04P5519

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740156909

ARCHITECT cSystem Theophylline SI Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P06-3A
In Commercial Distribution

  • 00380740156909 ()
05P063A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740156893

ARCHITECT cSystem Theophylline Conventional Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P06-1A
In Commercial Distribution

  • 00380740156893 ()
05P061A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740156886

ARCHITECT cSystem Phenytoin SI Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P08-3A
In Commercial Distribution

  • 00380740156886 ()
05P083A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740156879

ARCHITECT cSystem Phenytoin Conventional Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P08-1A
In Commercial Distribution

  • 00380740156879 ()
05P081A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740155865

Alinity c SerBENZSQ Assay File
Abbott GmbH
09P531A
In Commercial Distribution

  • 00380740155865 ()
09P531A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740155797

Alinity i tHCY-DIL Assay File
Abbott GmbH
09P283A
In Commercial Distribution

  • 00380740155797 ()
09P283A

  • Laboratory instrument/analyser application software IVD

NA - 04055207070086

CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution

  • 04055207070086 ()
5597706

  • Operating room audiovisual data/device management system application software

NA - 04055207070079

MEDIA ARCHIVE FILESHARE This module requires core.portal. It allows the storage of intraoperative data to an enabled directory in the hospital’s IT infrastructure. The module is required once for each file sharing approval.
Richard Wolf GmbH
5597203
Not in Commercial Distribution

  • 04055207070079 ()
5597203

  • Operating room audiovisual data/device management system application software

NA - 04055207070062

CORE.PORTAL SCHEDULING HL7 This module requires core.portal as a basis. It is used for transmitting demographic patient data or surgery scheduling data from a hospital information system via HL7 messages to core.portal. One module is required for each message type.
Richard Wolf GmbH
5597303
Not in Commercial Distribution

  • 04055207070062 ()
5597303

  • Operating room audiovisual data/device management system application software
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