AccessGUDID - DEVICE: iTOF (00860012119660)

GUDID

Device Identifier (DI) Information

Brand Name: iTOF
Version or Model: ITOFDEV01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NERBIO PRIVATE LIMITED

Primary DI Number: 00860012119660
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 854316966 *Terms of Use

Device Description: Neuromuscular transmission (NMT) monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOI	Stimulator, Nerve, Peripheral, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 35 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31c7de08-cad7-4460-bb14-4acc01560f11
Public Version Date: February 13, 2025
Public Version Number: 1
DI Record Publish Date: February 05, 2025