Sodium Electrode 2102

GUDID 00386100002978

ISE Sodium Electrode for use with EasyLyte analyzers

MEDICA CORPORATION

Sodium (Na+) electrode IVD Sodium (Na+) electrode IVD

• Primary Device ID: 00386100002978
• NIH Device Record Key: 427f6959-c9ef-46cc-8eb5-0503c5986dc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sodium Electrode
• Version Model Number: 2102
• Catalog Number: 2102
• Company DUNS: 112942404
• Company Name: MEDICA CORPORATION
• 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: true
• 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: 781-275-4892
• Email: technicalsupport@medicacorp.com
• Phone: 781-275-4892
• Email: technicalsupport@medicacorp.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386100002978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864872

FDA Product Code

• JGS: Electrode, Ion Specific, Sodium

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: 2018-12-10
• Device Publish Date: 2018-11-08

On-Brand Devices [Sodium Electrode]

• 00386100002978: ISE Sodium Electrode for use with EasyLyte analyzers
• 00386100002459: Sodium electrode for use with EasyStat and EasyElectrolyte Analyzers