AccessGUDID - DEVICE: EndoTool SubQ (00860003340622)

GUDID

Device Identifier (DI) Information

Brand Name: EndoTool SubQ
Version or Model: SubQ 2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MONARCH MEDICAL TECHNOLOGIES LLC

Primary DI Number: 00860003340622
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078665793 *Terms of Use
Previous DI: 00860003340608

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47903	Infusion pump medication-dosage application software	A software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDC	Calculator, Drug Dose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211160	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e874de9c-3104-489e-a991-c670b6652dde
Public Version Date: May 01, 2024
Public Version Number: 2
DI Record Publish Date: August 23, 2023