FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoTool IV
DI: 00860003340639
·
Model: 3.1
·
MONARCH MEDICAL TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndoTool IV
- Primary DI
- 00860003340639
- Version / Model
- 3.1
- Company Name
- MONARCH MEDICAL TECHNOLOGIES LLC
- Labeler DUNS
- 078665793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-02
- Public Version
- 1
- Public Version Date
- 2025-01-10
- Public Version Status
- New
- Public Device Record Key
- adb46189-0755-4dd6-83b5-852fa67bf5f2
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDC | Calculator, Drug Dose | Anesthesiology | 868.1890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860003340639 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241088 | 000 |