Potassium Electrode 2101

GUDID 00386100002961

ISE Potassium Electrode for use with EasyLyte analyzers

MEDICA CORPORATION

Potassium (K+) electrode IVD

• Primary Device ID: 00386100002961
• NIH Device Record Key: 21495e83-d40c-4c36-9972-4abaf86522fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Potassium Electrode
• Version Model Number: 2101
• Catalog Number: 2101
• 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	00386100002961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864872

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

On-Brand Devices [Potassium Electrode]

• 00386100002961: ISE Potassium Electrode for use with EasyLyte analyzers
• 00386100002466: Potassium Electrode for use with EasyStat and EasyElectrolyte Analyzers