FDA UDI
In Commercial Distribution
🇺🇸 United States
Glooko Web Application
DI: 00855093008026
·
Model: xx.yy (xx is model year and yy is a serial number)
·
GLOOKO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Glooko Web Application
- Primary DI
- 00855093008026
- Version / Model
- xx.yy (xx is model year and yy is a serial number)
- Company Name
- GLOOKO, INC.
- Labeler DUNS
- 078605143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-16
- Public Version
- 3
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 67928ef8-980b-4035-866a-eac9fa4cc3f1
Device Description
Glooko Web Application is a web based application that displays and analyzes retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 61087 | Clinical management support software | An application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Otherwise known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855093008026 | GS1 |