EndoTool SubQ

GUDID 00860003340622

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.

MONARCH MEDICAL TECHNOLOGIES LLC

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• Primary Device ID: 00860003340622
• NIH Device Record Key: e874de9c-3104-489e-a991-c670b6652dde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoTool SubQ
• Version Model Number: SubQ 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	00860003340608 [Previous]
GS1	00860003340622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211160

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: 2023-08-31
• Device Publish Date: 2023-08-23

Devices Manufactured by MONARCH MEDICAL TECHNOLOGIES LLC

• 00860003340622 - EndoTool SubQ: 2023-08-31EndoTool 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.
• 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: 2023-04-10 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