Reusable SpO2 Sensor, Neo, Bandage

GUDID 06944904005942

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose patient temperature probe, reusable

• Primary Device ID: 06944904005942
• NIH Device Record Key: 5a79e47d-684c-4c51-a37d-09dfcdb58fe0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable SpO2 Sensor, Neo, Bandage
• Version Model Number: 518B-30-72107
• 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: true
• 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	06944904005942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132038

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: 2018-07-06
• Device Publish Date: 2016-09-23

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