UltraviewSL L-91369

GUDID 10841522107757

91369 MONITOR, COMPACT

SPACELABS HEALTHCARE (WASHINGTON), INC

Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 10841522107757
• NIH Device Record Key: 5aa455d6-970c-43d5-aa9a-1cd4b20c5080
• Commercial Distribution Discontinuation: 2017-03-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: UltraviewSL
• Version Model Number: 91369
• Catalog Number: L-91369
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522107757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102422

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-22
• Device Publish Date: 2017-03-10

On-Brand Devices [UltraviewSL]

• 10841522108761: INTEGRATED MODULE HOUSING, REFURBISHED
• 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