BIS module (w accessory kit)

GUDID 06944904006673

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Patient monitoring system module, electroencephalographic

• Primary Device ID: 06944904006673
• NIH Device Record Key: 4e469676-412b-4fcd-b855-27833c76994a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIS module (w accessory kit)
• Version Model Number: 6800-30-50880
• 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: 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

Customer Support Contacts

• Phone: +8675581888998
• Email: service@mindray.com.cn

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904006673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143195

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH 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: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [BIS module (w accessory kit)]

• 06944904006673: 6800-30-50880
• 06944904096728: 115-046969-00