qube mini 91389

GUDID 10841522131462

QUBE MINI TRANSPORT MONITOR

SPACELABS HEALTHCARE (WASHINGTON), INC

Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 10841522131462
• NIH Device Record Key: d288228f-1bc2-4e59-ad1e-3b626e939b5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: qube mini
• Version Model Number: Qube Mini
• Catalog Number: 91389
• 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: 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	10841522131462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120616

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: 2024-12-12
• Device Publish Date: 2024-12-04

On-Brand Devices [qube mini]

• 10841522100239: QUBE MINI TRANSPORT MONITOR
• 10841522131462: QUBE MINI TRANSPORT MONITOR