iTOF ITOFDEV01
iTOF ITOFDEV01 is a Class II device made by Nerbio Private Limited, listed in FDA GUDID since 5 Feb 2025 (UDI-DI 00860012119660), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860012119660 | Date5 Feb 2025 | StatusListed |
Official records
- AccessGUDID record 00860012119660
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- iTOF
- Generic name
- Block-monitoring peripheral nerve electrical stimulation system
- Model / reference
- ITOFDEV01
- Description
- Neuromuscular transmission (NMT) monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
- Primary DI / UDI-DI
- 00860012119660
- FDA product code
- KOI
- GMDN term
- Block-monitoring peripheral nerve electrical stimulation system
- Device class
- Class II
- Regulation number
- 868.2775
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- High-level Disinfectant
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric).
- CONS. CURRENT PERIPH. NERVE LOC. NS232, NS262, NS272 by Fisher & Paykel Electronics, Ltd.
- CARESCAPE B650 MBB313 by GE Healthcare Finland Oy
- AS/3 NMT MODULE by Datex Medical Instrumentation, Inc.
- INFINITY TRIDENT NMT POD by Draeger Medical Systems, Inc.
- TOF-WATCH S by Organon Teknika Corp.
- TOF-WATCH by Organon Teknika Corp.
- MAXISTIM by Life-Tech Intl., Inc.
- CARESCAPE B450 MBA313 by GE Healthcare Finland Oy
- DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES by GE Healthcare
- CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) by FISHER & PAYKEL HEALTHCARE, INC.