BIS

Basic Information

• Brand Name: BIS
• Primary DI: 10884521808270
• Version / Model: PMB4000
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-28
• Public Version: 3
• Public Version Date: 2025-06-24
• Public Version Status: Update
• Public Device Record Key: 8ca9b474-78f7-4591-adc5-9814bf4da338

Device Description

BIS (TM) Advance Monitor

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: MR Unsafe
• 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
OLW	Index-generating electroencephalograph software	Neurology	882.1400	2
OLT	Non-normalizing quantitative electroencephalograph software	Neurology	882.1400	2
OMC	Reduced- montage standard electroencephalograph	Neurology	882.1400	2
ORT	Burst suppression detection software for electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521808270	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 54 – 107 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 0 – 35 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 54 – 107 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity