FDA UDI
In Commercial Distribution
🇺🇸 United States
Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application
DI: 00855093008002
·
Model: 5.x
·
GLOOKO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application
- Primary DI
- 00855093008002
- Version / Model
- 5.x
- Company Name
- GLOOKO, INC.
- Labeler DUNS
- 078605143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-22
- Public Version
- 5
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 3eb66960-d617-4339-8dcd-81eaf5b3c445
Device Description
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NDC | Calculator, Drug Dose | Anesthesiology | 868.1890 | 2 |
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 | 00855093008002 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171450 | 000 |