MR Na/K Check Solution

GUDID 06936415904661

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Potassium (K+) IVD, kit, ion-selective electrode (ISE)

• Primary Device ID: 06936415904661
• NIH Device Record Key: 520f9fbf-5e90-4d9f-9b8b-369fdbc77500
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Na/K Check Solution
• Version Model Number: 105-011386-00
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936415904661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160370

FDA Product Code

• CEM: Electrode, Ion Specific, Potassium

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: 2026-02-02
• Device Publish Date: 2026-01-23

Devices Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

• 06936415904661 - MR Na/K Check Solution: 2026-02-02
• 06936415904661 - MR Na/K Check Solution: 2026-02-02
• 06936415904678 - MR Detergent Solution: 2026-02-02
• 06936415904685 - MR Buffer Solution: 2026-02-02
• 06944904084459 - Chemistry Analyzer: 2026-02-02
• 06903053010641 - M-30CFL LYSE: 2026-01-30
• 06936415908805 - M-30CFL LYSE: 2026-01-30
• 06936415908812 - M-30CFL LYSE: 2026-01-30
• 06936415994457 - PROBE CLEANSER: 2026-01-30