FDA.reportPublic FDA data

Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application

Primary DI
00855093008002
Brand
Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application
Company
GLOOKO, INC.
Model
5.x
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.
Published
2018-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NDCCalculator, Drug Dose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDCCalculator, Drug DoseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171450000Glooko Mobile Insulin Dosing SystemGlooko, Inc.2018-02-02NDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855093008002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855093008002008550930080028550930080020855093008002

GMDN Terms#

Term, Definition table
TermDefinition
Clinical decision management support softwareAn application software program intended to facilitate clinical management decisions by receiving 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, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, guidelines links) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app.

Regulatory Flags#

DUNS number
078605143
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855093008033Glooko Mobile Application5.xx2021-02-16
00855093008040Cornerstones4Care® Powered by Glooko Mobile Application1.xx2021-02-16
00855093008026Glooko Web Applicationxx.yy (xx is model year and yy is a serial number)2021-02-16
00855093008019Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard18.x2018-06-11

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Primary DI, Brand, Company table
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00763000974589InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
00763000974596InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
B553202145RX0LivingConnected Diabetes RxWELLDOC, INC.NDC2025-04-11
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00850005949558BioButton (Reprocessed)BIOINTELLISENSE, INC.NDC2025-02-19
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B553202141OTC0LivingConnected Diabetes RxWELLDOC, INC.NDC2024-12-04