Insulin Insights™

Primary DI
00860001009804
Brand
Insulin Insights™
Company
MELLITUS HEALTH, INC.
Model
Version 1
Device description
Insulin Insights™ is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. Insulin Insights™ evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). Insulin Insights™ is designed for use by healthcare professionals. Insulin Insights™ is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
Published
2019-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K160673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160673000Insulin Algorithms SystemInsulin Algorithms2017-06-07NDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001009804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001009804008600010098048600010098040860001009804

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.

Contacts#

Phone, Email table
PhoneEmail
(424) 218-0792info@mellitushealth.com

Regulatory Flags#

DUNS number
079173054
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150002375MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00199150002382MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00860008440129iSage Rx Amalgam RX, Inc.NDC2026-04-22
B553202153OTC0Conifer Connect DiabetesWELLDOC, INC.NDC2026-03-30
00860015223906UpDocUpDoc Inc.NDC2026-01-13
B553202401OTC0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202402RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202403OTC0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202404RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202405RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
00199150047000MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047024MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047048MiniMed 780G Insulin pumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047055MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
07649994217037T1D1Comerge AGNDC2025-08-28
10385082000009Omnipod DASH PDMInsulet CorporationNDC2025-08-25
B553202251OTC0WelldocWELLDOC, INC.NDC2025-05-29
B553202252RX0WelldocWELLDOC, INC.NDC2025-05-29
B553202253OTC0WelldocWELLDOC, INC.NDC2025-05-29
B553202254RX0WelldocWELLDOC, INC.NDC2025-05-29
B553202256RX0WelldocWELLDOC, INC.NDC2025-05-29
00763000974589InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
00763000974596InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
B553202145RX0LivingConnected Diabetes RxWELLDOC, INC.NDC2025-04-11
00763000489953InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.NDC2025-03-08
00763000489960InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.NDC2025-03-08
00850005949558BioButton (Reprocessed)BIOINTELLISENSE, INC.NDC2025-02-19
00850005949565BioButton (Reprocessed, NF Version)BIOINTELLISENSE, INC.NDC2025-02-19
00860003340639EndoTool IV MONARCH MEDICAL TECHNOLOGIES LLCNDC2025-01-02
B553202141OTC0LivingConnected Diabetes RxWELLDOC, INC.NDC2024-12-04