DEVICE: Boppli (00860007282928)

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Device Record History
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Device Identifier (DI) Information
Boppli
53-0003
In Commercial Distribution

Pyrames Inc.
00860007282928
GS1

1
080935399 *Terms of Use
Boppli Blood Pressure Monitor - Bedside Device - Device
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

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?
63088 Blood glucose/blood pressure monitoring system, point-of-care
A collection of devices intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K223873 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
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 20 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
40082a00-94d0-4c5c-a47e-9c0c2870ab4a
March 10, 2025
3
November 30, 2023
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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
No
No
Yes CLOSE

Customer Contact

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No Customer Contact currently defined
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