EndoTool IV

GUDID 00860003340639

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.

MONARCH MEDICAL TECHNOLOGIES LLC

Infusion pump medication-dosage application software

• Primary Device ID: 00860003340639
• NIH Device Record Key: adb46189-0755-4dd6-83b5-852fa67bf5f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoTool IV
• Version Model Number: 3.1
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003340639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241088

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: 2025-01-10
• Device Publish Date: 2025-01-02

On-Brand Devices [EndoTool IV ]

• 00860003340615: EndoTool is a glucose management software system, designed for use by healthcare professionals i
• 00860003340639: EndoTool IV is a glucose management software system used by healthcare professionals in all inp