DEVICE: FORA (00898939002444)

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Device Record History
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Device Identifier (DI) Information
FORA
D20
In Commercial Distribution

FORA CARE INC.
00898939002444
GS1

1
004340807 *Terms of Use
Blood Glucose Plus Blood Pressure Monitoring System
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
Yes
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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?
47654 Home-use/point-of-care glucose rapid test/blood pressure system analyser
A portable, battery-powered instrument used with other devices (e.g., reagents, test strips, a blood pressure cuff, and accessories) to semi-quantitatively measure glucose in a specimen of whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. The measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. The device is normally available [non-prescription] over-the-counter (OTC) for home-use, but may also be used in a clinical setting for multi-patient monitoring of blood glucose and blood pressure.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive
NBW System, Test, Blood Glucose, Over The Counter
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K091814 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
46d76690-629f-4d3d-bcb6-c0c7b8bf84a0
July 19, 2024
4
October 24, 2017
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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
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No
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Customer Contact

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No Customer Contact currently defined
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