rSO2 module

GUDID 06936415904074

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cerebral oximeter

• Primary Device ID: 06936415904074
• NIH Device Record Key: 49304f73-f60b-4113-9d2d-ae10a4783757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rSO2 module
• Version Model Number: 115-037264-00
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	06936415904074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182075

FDA Product Code

• MUD: Oximeter, Tissue Saturation

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: 2020-05-05
• Device Publish Date: 2020-04-27

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