Xprezzon 040-1765-00

GUDID 10841522129179

KIT, MODULE RECORDER, 91393

SPACELABS HEALTHCARE (WASHINGTON), INC

General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 10841522129179
• NIH Device Record Key: ef1a77f1-d3c5-4110-a88f-ac1655cec16a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xprezzon
• Version Model Number: Xprezzon Monitor
• Catalog Number: 040-1765-00
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522129179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112962

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-17
• Device Publish Date: 2024-06-07

On-Brand Devices [Xprezzon]

• 10841522100093: STATIONARY MONITOR, 91393, REFURBISHED
• 10841522100109: 91393 STATIONARY MONITOR, LOANER
• 10841522100079: Bedside Monitor
• 10841522129179: KIT, MODULE RECORDER, 91393