DEVICE: Expanse Laboratory/Genetics/Microbiology/Anatomical Pathology (00863529000155)
Device Identifier (DI) Information
Expanse Laboratory/Genetics/Microbiology/Anatomical Pathology
Expanse
In Commercial Distribution
MEDICAL INFORMATION TECHNOLOGY, INC.
Expanse
In Commercial Distribution
MEDICAL INFORMATION TECHNOLOGY, INC.
MEDITECH's Laboratory application closely integrates requisition, specimen processing, and patient information with data in Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry through seamless integration with laboratory instruments. Authorized users have the ability to view laboratory results via a specimen inquiry or a patient summary.
MEDITECH's Genetics application closely integrates requisition, specimen processing, and patient information with data in an Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry. Authorized users have the ability to view genetic test results via a specimen inquiry or a patient summary.
MEDITECH's Microbiology application closely integrates requisition, specimen processing, and patient information with data in the Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient processing for collection and resulting of specimens including: bacteriology, mycology, parasitology, virology, and mycobacteriology.
MEDITECH's Anatomical Pathology application automates the data handling needs of the Pathology department with features for recording, storing, coding, searching, and reporting Pathology cases. MEDITECH's EHR gives users the ability to view Radiology reports and lab results pertinent to the case, and to integrate relevant data into Pathology reports. Authorized users have the ability to view Anatomic Pathology results from within the network.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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44082 | Clinical laboratory information system application software |
An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JQP | Calculator/Data Processing Module, For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
29bd5452-f0b0-4cd6-80fe-979ec506dc37
February 13, 2023
1
February 03, 2023
February 13, 2023
1
February 03, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined