Star 60

GUDID 18904269450783

Multipara Patient monitoring system

Skanray Technologies Private Limited

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 18904269450783
• NIH Device Record Key: 02f51ef1-f815-4c41-90b6-d78cc1174b78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Star 60
• Version Model Number: F3-86-390-0910-97
• 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	18904269450783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151512

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-05-24

On-Brand Devices [Star 60]

• 18904269450769: Multipara Patient monitoring system
• 01890426945073: Multipara Patient monitoring system
• 18904269450783: Multipara Patient monitoring system