EndoTool IV (3.1)
Monarch Medical Technologies
Monarch Medical Technologies
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009864844 | 3009864844 | Monarch Medical Technologies | 1 | N | 2026-01-01 | 112 S. Tryon Street Suite 800 Charlotte NC US 28284 |
| 3009864844 | 3009864844 | Monarch Medical Technologies | 1 | N | 2020-04-25 | 4400 Stuart Andrew Blvd. Suite N Charlotte NC US 28217 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 344657 | 1292864256 | K241088 | EndoTool IV (3.1) | NDC | 2024-12-11 |
| 344657 | 2038561131 | K211160 | EndoTool SubQ 2.1 | NDC | 2021-10-28 |
| 344657 | 1762015392 | K201619 | EndoTool IV System | NDC | 2020-08-07 |
| 344657 | 1481484535 | K200443 | EndoTool IV 1.10 | NDC | 2020-03-17 |
| 146806 | 1839442293 | K200443 | EndoTool IV 1.10 | NDC | 2020-03-17 |
| 146806 | 1262082153 | K180366 | EndoTool SubQ | NDC | 2018-09-20 |
| 146806 | 1446800963 | K142918 | EndoTool SubQ | NDC | 2015-04-24 |
| 146806 | 1822004172 | K132547 | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) | NDC | 2014-04-17 |
| 146806 | 1840532581 | K053137 | ENDOTOOL DRUG DOSE CALCULATOR | NDC | 2006-06-14 |
| 146806 | 1579632512 | K011571 | TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE | NDC | 2001-08-09 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NDC | 10 | 2024-12-11 |
PMN#
EndoTool SubQ 2.1
Monarch Medical Technologies, LLC
EndoTool IV System
Monarch Medical Technologies, LLC
EndoTool IV 1.10
Monarch Medical Technologies, LLC
EndoTool SubQ
MONARCH MEDICAL TECHNOLOGIES
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
MONARCH MEDICAL TECHNOLOGIES
GUDID#
EndoTool IV - EndoTool IV is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. EndoTool adjusts and maintains a patient’s glucose level within a configurable clinician-determined target range by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for recovery or supplementation, and subcutaneous dosing for the transition from IV dosing. EndoTool IV logic is not a substitute for but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
2025-01-02
EndoTool - EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
2022-09-06
EndoTool IV - EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
2023-03-31
EndoTool SubQ - EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient’s next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with hyperglycemia including adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) and when indicated a carbohydrate dose based on the prescribing healthcare Provider’s nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.
2023-08-23