Skyline 55 wireless

GUDID 18904269451537

Central Nursing Station or Central Monitoring System

Skanray Technologies Private Limited

Patient monitoring system central station monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor

• Primary Device ID: 18904269451537
• NIH Device Record Key: d2dd0fab-9daa-42a3-b603-e78c4c223a97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skyline 55 wireless
• Version Model Number: F3-87-390-0075-46
• Company DUNS: 650662203
• Company Name: Skanray Technologies Private Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	18904269451537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092153

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without 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: 2019-06-13
• Device Publish Date: 2019-06-05

On-Brand Devices [Skyline 55 wireless]

• 18904269451537: Central Nursing Station or Central Monitoring System
• 18904269451520: Central Nursing Station or Central Monitoring System