Skyline 55 wireless

GUDID 18904269451537

Central Nursing Station or Central Monitoring System

Skanray Technologies Private Limited

Patient monitoring system central station 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