FDA UDI
In Commercial Distribution
🇺🇸 United States
Mechanomyography Sensor (MMG) for Neuromuscular Transmission Monitor TOF3D
DI: 04255629200751
·
Model: 5750126
·
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Mechanomyography Sensor (MMG) for Neuromuscular Transmission Monitor TOF3D
- Primary DI
- 04255629200751
- Version / Model
- 5750126
- Catalog Number
- 5750126
- Company Name
- MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Labeler DUNS
- 324416379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-21
- Public Version
- 1
- Public Version Date
- 2025-12-01
- Public Version Status
- New
- Public Device Record Key
- 6e53b3be-7b03-43b9-b5e1-454371c7600a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KOI | Stimulator, Nerve, Peripheral, Electric | Anesthesiology | 868.2775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35722 | Block-monitoring peripheral nerve electrical stimulation system | An assembly of battery-powered devices designed to apply electrical stimuli to a peripheral nerve (e.g., the ulnar or lower extremity nerve) to assess the adequacy of neuromuscular block during surgery, and its reversal during the recovery period. The system typically uses four kinds of stimulation: twitch, train-of-four, tetanic, and double burst. It typically includes conventional electrocardiographic electrodes and/or bipolar surface electrodes (ball electrodes), and a pulse generator. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04255629200751 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250887 | 000 |