FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Dexcom Portrait on the Web
DI: B059POW3500010
·
Model: 350-0010
·
SWEETSPOT DIABETES CARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dexcom Portrait on the Web
- Primary DI
- B059POW3500010
- Version / Model
- 350-0010
- Catalog Number
- 350-0010
- Company Name
- SWEETSPOT DIABETES CARE, INC.
- Labeler DUNS
- 963889204
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-26
- Public Version
- 5
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- b9fea405-cc6b-4bdd-bd52-7d073f185048
- Distribution End Date
- 2016-12-30
Device Description
Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software | Clinical Chemistry | 862.2120 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B059POW3500010 | HIBCC |