EndoTool - EndoTool is a glucose management software system, - MONARCH MEDICAL TECHNOLOGIES LLC

Duns Number:078665793

Device Description: EndoTool is a glucose management software system, designed for use by healthcare professio 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.

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More Product Details

Catalog Number

-

Brand Name

EndoTool

Version/Model Number

None

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180366,K200443,K201619

Product Code Details

Product Code

NDC

Product Code Name

Calculator, Drug Dose

Device Record Status

Public Device Record Key

214b42f6-dbac-459e-9bba-765ea3983187

Public Version Date

September 14, 2022

Public Version Number

1

DI Record Publish Date

September 06, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MONARCH MEDICAL TECHNOLOGIES LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1