AccessGUDID - DEVICE: UltraviewSL (10841522100253)

GUDID

Device Identifier (DI) Information

Brand Name: UltraviewSL
Version or Model: Module: BISx
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 91482
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522100253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: MODULE BISX, 91482

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?
37323	Patient monitoring system module, electroencephalographic	A small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMC	Reduced- montage standard electroencephalograph
OLW	Index-generating electroencephalograph software
ORT	Burst suppression detection software for electroencephalograph
OLT	Non-normalizing quantitative electroencephalograph software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060900	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
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 19 and 101 KiloPascal
Storage Environment Temperature: between -25 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14170906-4a58-4422-9490-3a503eb01eb5
Public Version Date: June 04, 2024
Public Version Number: 9
DI Record Publish Date: October 10, 2016