ISE Cleaning Solution Kit 5421

GUDID 00386100002794

ISE Cleaning Solution Kit for use with EasyElectrolyte Analyzers

MEDICA CORPORATION

Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system

• Primary Device ID: 00386100002794
• NIH Device Record Key: efa5ed1a-fb13-4984-b6da-6b90e0b316d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Cleaning Solution Kit
• Version Model Number: 5421
• Catalog Number: 5421
• 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	00386100002794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000926

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: 2019-01-11
• Device Publish Date: 2018-12-11

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