EndoTool IV

GUDID 00860003340615

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.

MONARCH MEDICAL TECHNOLOGIES LLC

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• Primary Device ID: 00860003340615
• NIH Device Record Key: 6f993fa6-e2c5-4fa3-a5b2-fa28c744a46f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoTool IV
• Version Model Number: EndoTool IV 2.0
• Company DUNS: 078665793
• Company Name: MONARCH MEDICAL TECHNOLOGIES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003340615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200443

FDA Product Code

• NDC: Calculator, Drug Dose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-10
• Device Publish Date: 2023-03-31

Devices Manufactured by MONARCH MEDICAL TECHNOLOGIES LLC

• 00860003340622 - EndoTool SubQ: 2023-08-31 EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual pat
• 00860003340615 - EndoTool IV: 2023-04-10EndoTool 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.
• 00860003340615 - EndoTool IV: 2023-04-10 EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to r
• 00860003340608 - EndoTool: 2022-09-14 EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to r