DEVICE: Dexcom Portrait on the Web (B059POW3500010)
Device Identifier (DI) Information
Dexcom Portrait on the Web
350-0010
Not in Commercial Distribution
350-0010
SWEETSPOT DIABETES CARE, INC.
350-0010
Not in Commercial Distribution
350-0010
SWEETSPOT DIABETES CARE, INC.
Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.
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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59231 | Noninvasive interstitial-fluid glucose monitoring device |
An electrically-powered, noninvasive, portable device designed to continuously measure and record interstitial-fluid glucose concentrations, typically for detecting trends and tracking patterns in a patient with diabetes mellitus. It includes a monitor with optical sensor that measures interstitial glucose concentrations using Raman spectroscopy, and a display which can be a dedicated electronic device or a software application that runs on portable electronics (e.g., smartphone). It may be used in the home and clinical setting, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PHV | Continuous Glucose Monitor Retrospective Data Analysis Software |
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
b9fea405-cc6b-4bdd-bd52-7d073f185048
November 28, 2022
4
August 26, 2016
November 28, 2022
4
August 26, 2016
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
[?]
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