BeneVision Central Monitoring System 115-034411-00

GUDID 06944904055282

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Multiple-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 06944904055282
• NIH Device Record Key: 5b6a9d45-f3a2-41bc-88ab-3150f7605e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BeneVision Central Monitoring System
• Version Model Number: BeneVision
• Catalog Number: 115-034411-00
• Company DUNS: 654671304
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904055282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150632

FDA Product Code

• MSX: System,Network And Communication,Physiological Monitors

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: 2020-02-06
• Device Publish Date: 2015-10-20

On-Brand Devices [BeneVision Central Monitoring System]

• 06944904055312: BeneVision
• 06944904055305: BeneVision
• 06944904055299: BeneVision
• 06944904055282: BeneVision
• 06944904055275: BeneVision
• 06944904055152: BeneVision