Auto Hematology Analyzer BC-5390

GUDID 06944904052113

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD

• Primary Device ID: 06944904052113
• NIH Device Record Key: cfc25683-1fc3-4886-8a33-f93ae0914731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auto Hematology Analyzer BC-5390
• Version Model Number: BC-5390
• 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: 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
• 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
• 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
• 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	06944904052113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143348

FDA Product Code

• GKZ: Counter, differential cell

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: 2019-12-23
• Device Publish Date: 2016-09-23

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