AccessGUDID - DEVICE: BIS (20884521134505)

GUDID

Device Identifier (DI) Information

Brand Name: BIS
Version or Model: 186-0106-PH
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 20884521134505
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Quatro Sensor Kit, (25) 186-0106

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 [?]
K072286	000
K093183	000
K143506	000

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 -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ed1567d-f801-40de-b79b-3d0b4fa512c2
Public Version Date: June 13, 2025
Public Version Number: 12
DI Record Publish Date: October 20, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 30884521134502 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES