ISE Reagent Pack 5423-0041

GUDID 00386100002282

ISE Reagent Pack for use with EasyRA Analyzers

MEDICA CORPORATION

Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator

• Primary Device ID: 00386100002282
• NIH Device Record Key: 7e2bb0ee-681f-41ef-8520-fea897e87908
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Reagent Pack
• Version Model Number: 5423-0041
• Catalog Number: 5423-0041
• 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	00386100002282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070057

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2019-03-11
• Device Publish Date: 2019-02-14

On-Brand Devices [ISE Reagent Pack]

• 00386100002817: ISE Reagent Pack for use with EasyElectrolyte Analyzers
• 00386100002282: ISE Reagent Pack for use with EasyRA Analyzers