Na/K Solution Pack 2109

GUDID 00386100003029

Na/K Solution Pack for use with EasyLyte Analyzers

MEDICA CORPORATION

Multiple electrolyte IVD, calibrator

• Primary Device ID: 00386100003029
• NIH Device Record Key: ace40dce-a03b-41a1-ba76-bf820f06f258
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Na/K Solution Pack
• Version Model Number: 2109
• Catalog Number: 2109
• 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	00386100003029 [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: 2019-01-04
• Device Publish Date: 2018-12-04

On-Brand Devices [Na/K Solution Pack]

• 00386100003081: Na/K Solution Pack for use with EasyLyte Analyzers
• 00386100003029: Na/K Solution Pack for use with EasyLyte Analyzers