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.
B059POW3500010
HIBCC
December 30, 2016
1
963889204 *Terms of Use
Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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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
Noninvasive interstitial-fluid glucose monitoring system An assembly of portable electronic battery-powered devices designed to continuously measure and record interstitial-fluid glucose concentrations, typically for detecting trends and tracking patterns in a patient with diabetes mellitus, using a noninvasive technique. 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 or clinical setting, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.
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FDA Product Code

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Product Code Product Code Name
PHV Continuous Glucose Monitor Retrospective Data Analysis Software
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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

b9fea405-cc6b-4bdd-bd52-7d073f185048
March 29, 2018
2
August 26, 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
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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