AccessGUDID - DEVICE: BIS (10884521812369)

GUDID

Device Identifier (DI) Information

Brand Name: BIS
Version or Model: 186-0224-NK-RFB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521812369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: BISX4 Module Refurbished, Software Version 1.15; For use with Nihon Kohden Monitors

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
41920	Anaesthesia depth monitor	A mains electricity (AC-powered) device intended to be used to detect, process, and display the signals recorded from an unconscious patient (in a state of anaesthesia), showing the degree of consciousness. It is based upon the bispectral index (BIS) analysis of the electroencephalogram waveform and other features of this, enabling detection of, e.g., levels of sedation, loss of consciousness, and recall. It is used during anaesthesia administration and in trauma.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLW	Index-generating electroencephalograph software

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Fragile, Keep dry, This side up
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 360 and 800 Millimeter of Mercury
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 12 and 107 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 39515d36-3ad3-4441-b30b-85fe9142c918
Public Version Date: June 13, 2025
Public Version Number: 4
DI Record Publish Date: November 11, 2021