K ELECTRODE, ISE MODULE 5202

GUDID 05999883586693

Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a device intended to measure potassium in serum, plasma, and urin

Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Resz

Potassium (K+) electrode IVD

• Primary Device ID: 05999883586693
• NIH Device Record Key: c9ef5ee3-6062-4ded-9369-5d0014614655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K ELECTRODE, ISE MODULE
• Version Model Number: K+ Electrode
• Catalog Number: 5202
• Company DUNS: 427395277
• Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Resz
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: +1207-450-4228
• Email: John.Roche@diatron.com

Device Dimensions

• Height: 60 Millimeter
• Depth: 40 Millimeter
• Width: 90 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05999883586693 [Primary]
GS1	15999883586690 [Package]; Package: box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101741

FDA Product Code

• CEM: Electrode, Ion Specific, Potassium

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: 2018-07-06
• Device Publish Date: 2016-10-06

Devices Manufactured by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Resz

• 15999883586683 - NA ELECTRODE, ISE MODULE: 2018-07-06 Clinical Chemistry Test Systems / Sodium test system. A sodium test system is a device intended to measure sodium in serum, pla
• 05999883586693 - K ELECTRODE, ISE MODULE: 2018-07-06Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a device intended to measure potassium in serum, plasma, and urin
• 05999883586693 - K ELECTRODE, ISE MODULE: 2018-07-06 Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a device intended to measure potassium in s
• 15999883586706 - CL ELECTRODE, ISE MODULE: 2018-07-06 Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a device intended to measure the level of chl