endo.digital
Basic Information
- Brand Name
- endo.digital
- Primary DI
- 07290017735023
- Version / Model
- 02.XX.YY
- Catalog Number
- N/A
- Company Name
- DREAMED DIABETES LTD
- Labeler DUNS
- 600230110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-20
- Public Version
- 1
- Public Version Date
- 2022-09-28
- Public Version Status
- New
- Public Device Record Key
- 0aabefcf-ea49-44b8-a01b-ee497db06e07
Device Description
endo.digital platform is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG) and to patients with Type 2 diabetes on basal-bolus therapy via multiple daily injections (MDI), a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). endo.digital gathers and analyses information inputted through the endo.digital Uploader or qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by endo.digital includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care. Following data collection and analysis, the endo.digital platform generates results containing summary data and recommendations for adjustments to the patient’s insulin therapy parameters, including a basal and bolus plan. endo.digital may also advise behavioral changes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patients.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 880.6310 | 1 |
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software | Clinical Chemistry | 862.2120 | 1 |
| QCC | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals | Clinical Chemistry | 862.1358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63261 | Ambulatory insulin infusion pump remote control/blood glucose analyser | A portable electronic device designed to: 1) remotely control an electronic ambulatory insulin infusion pump; and 2) measure blood glucose levels to aid a diabetes mellitus patient in self-management of insulin therapy. It consists of a wireless unit that interfaces with the pump (not included) to control and program pump functions and receive pump status information, and which incorporates a blood glucose meter and built-in test strip port for the in vitro quantitative measurement of glucose in harvested capillary blood. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017735023 | GS1 |