qube mini 91389

GUDID 10841522100239

QUBE MINI TRANSPORT MONITOR

SPACELABS HEALTHCARE (WASHINGTON), INC

Transportable physiologic monitoring system

• Primary Device ID: 10841522100239
• NIH Device Record Key: faf5c2dd-ff63-4f07-ac38-82fde336b35b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: qube mini
• Version Model Number: 91389
• 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: 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522100239 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-06
• Device Publish Date: 2016-11-29

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• 10841522131141 - Xhibit: 2024-07-12 DISPLAY,21.5",CAPACITIVE TOUCH,BLACK,ANTI-GLARE
• 10841522100710 - SENTINEL: 2024-07-03 SENTINEL
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