Urine Standard (Indirect)(FDA)

GUDID 06944904084985

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Multiple electrolyte IVD, calibrator

• Primary Device ID: 06944904084985
• NIH Device Record Key: 72745802-8ba4-4eab-b48f-885475059710
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Standard (Indirect)(FDA)
• Version Model Number: 105-011385-00
• 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: true
• 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	06944904084985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160370

FDA Product Code

• JIT: CALIBRATOR, SECONDARY

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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