AG Module(O2/package/accessory)

GUDID 06944904000244

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Anaesthesia unit, mobile Anaesthesia unit, mobile Anaesthesia unit, mobile Anaesthesia unit, mobile

• Primary Device ID: 06944904000244
• NIH Device Record Key: 3fb91fa1-0d4c-4f26-8090-b03fdf343c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AG Module(O2/package/accessory)
• Version Model Number: 115-051561-00
• 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: true
• 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
• Phone: +8675581888998
• Email: service@mindray.com.cn
• Phone: +8675581888998
• Email: service@mindray.com.cn
• Phone: +8675581888998
• Email: service@mindray.com.cn

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904000244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171292

FDA Product Code

• BSZ: Gas-Machine, Anesthesia

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: 2020-05-21
• Device Publish Date: 2020-05-13

On-Brand Devices [AG Module(O2/package/accessory)]

• 06944904096636: 115-044874-00
• 06944904000244: 115-051561-00