DEVICE: Pylo Health (00860011521204)
Device Identifier (DI) Information
Pylo Health
GL1-LTE
In Commercial Distribution
Prevounce Health, Inc
GL1-LTE
In Commercial Distribution
Prevounce Health, Inc
Pylo Blood Glucose Meter Device GL1-LTE
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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63087 | Blood glucose/blood pressure monitoring system, home-use |
A collection of devices intended for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NBW | System, Test, Blood Glucose, Over The Counter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K223722 | 000 |
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
28e122fc-02c2-42c2-8d00-2ee8f9f52c93
April 23, 2024
1
April 15, 2024
April 23, 2024
1
April 15, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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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
[?]
No Customer Contact currently defined