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iTOF

FDA UDI

Class II (US FDA UDI)

by Nerbio Private Limited

Identity

Trade Name
iTOF FDA UDI
Generic Name
Block-monitoring peripheral nerve electrical stimulation system FDA UDI
Device Name
Neuromuscular transmission (NMT) monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit. FDA UDI
Model / Reference
ITOFDEV01 FDA UDI
Description
Neuromuscular transmission (NMT) monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit. FDA UDI

Identifiers

Primary DI / UDI-DI
00860012119660 FDA UDI
FDA Product Code
KOI FDA UDI
GMDN Term
Block-monitoring peripheral nerve electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2775 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Block-monitoring peripheral nerve electrical stimulation system

iTOF by Nerbio Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Block-monitoring peripheral nerve electrical stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nerbio Private Limited

Sources (1)

  • FDA UDI 31c7de08-cad7-4460-bb14-4acc01560f11 35 fields · synced May 31, 2026