DEVICE: ROMA Calculation Tool Using Elecsys Assay (00365702702127)

Device Identifier (DI) Information

ROMA Calculation Tool Using Elecsys Assay
07113358001
In Commercial Distribution
07113358001
Roche Diagnostics GmbH
00365702702127
GS1

1
315028860 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Clinical data collection/management information system application software An application software program, routines, and/or algorithms designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is installed to provide transportation of discrete, waveform and infusion data from medical devices, as well as laboratory data, into an electronic medical record (EMR) and/or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests.
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FDA Product Code

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Product Code Product Code Name
ONX ovarian adnexal mass assessment score test system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153607 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

dc4533b4-1c65-4f8a-97f2-44ea0a9a8d6a
July 06, 2018
3
October 28, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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