Intesys Clinical Suite 92876

GUDID 10841522123597

CUSTOM TRENDS,92876

SPACELABS HEALTHCARE (WASHINGTON), INC

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• Primary Device ID: 10841522123597
• NIH Device Record Key: 54726fb5-1a72-4bc1-9d4a-03ff9e390188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intesys Clinical Suite
• Version Model Number: Smart Disclosure
• Catalog Number: 92876
• 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: 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	10841522123597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110779

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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: 2023-08-18
• Device Publish Date: 2018-08-08

On-Brand Devices [Intesys Clinical Suite]

• 10841522123580: SMART DISCLOSURE,92810
• 10841522123658: ENTERPRISE NETWORK INTERFACE,92848
• 10841522123627: PRINT MANAGER,92881
• 10841522123610: VITAL SIGNS VIEWER,92880
• 10841522123603: 12 LEAD ECG INTERFACE,92877
• 10841522123597: CUSTOM TRENDS,92876