UltraviewSL 91482

GUDID 10841522100253

MODULE BISX, 91482

SPACELABS HEALTHCARE (WASHINGTON), INC

Patient monitoring system module, electroencephalographic

• Primary Device ID: 10841522100253
• NIH Device Record Key: 14170906-4a58-4422-9490-3a503eb01eb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraviewSL
• Version Model Number: 91482
• Catalog Number: 91482
• Company DUNS: 145581588
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522100253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060900

FDA Product Code

• OMC: Reduced- montage standard electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-08
• Device Publish Date: 2016-10-10

On-Brand Devices [UltraviewSL]

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• 10841522113109: MULTIGAS MODULE,92518
• 10841522100253: MODULE BISX, 91482
• 10841522108730: MONITOR, BEDSIDE, REFURBISHED
• 10841522100215: MONITOR,BEDSIDE
• 10841522108723: ADVANCED COMPACT MONITOR, REFURBISHED
• 10841522108716: MONITOR, COMPACT, REFURBISHED
• 10841522107757: 91369 MONITOR, COMPACT
• 10841522102981: KIT, DM3 UPDATE, V1.8
• 10841522102974: KIT, DM3 UPDATE, V1.7
• 10841522108792: OPTION, SPACELABS SPO2, REFURBISHED
• 10841522112430: MODULE, MS/SS DUAL CAPNOGRAPHY
• 10841522100260: INTEGRATED MODULE HOUSING
• 10841522108778: OPTION, MASIMO SPO2, REFURBISHED
• 10841522108754: OPTION, BISX BASE MODULE, REFURB