Ultraview SL 700-0027-00

GUDID 10841522122613

CABLE ASSEMBLY,ADAPTOR,CO

SPACELABS HEALTHCARE (WASHINGTON), INC

Patient monitoring system module, multifunction

• Primary Device ID: 10841522122613
• NIH Device Record Key: c533475e-ccfb-44b6-a8e6-9e351047d0f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultraview SL
• Version Model Number: 91496
• Catalog Number: 700-0027-00
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522122613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103142

FDA Product Code

• DXN: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-04-20
• Device Publish Date: 2017-05-31

On-Brand Devices [Ultraview SL]

• 10841522122637: CABLE,ASSY ADAPTER MPT/SPO2 NELL
• 10841522122613: CABLE ASSEMBLY,ADAPTOR,CO
• 10841522122606: CABLE ASSEMBLY,ADAPTOR,T1-T2
• 10841522122590: CABLE ASSY, ADAPTOR, P1-P2, 91496
• 10841522122583: CABLE ASSY,ADAPTOR,P1-2/P3-4,91496
• 10841522106439: OPTION,SPACELABS SPO2
• 10841522106422: OPTION,NELLCOR OXIMAX SPO2
• 10841522106415: OPTION, MASIMO SET SPO2
• 10841522122620: CABLE ASSEMBLY,SPO2