Reagent Module 7101-0000

GUDID 00386100002664

EasyStat Reagent Module

MEDICA CORPORATION

Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator

• Primary Device ID: 00386100002664
• NIH Device Record Key: 99eaa1de-6841-489e-99b8-548101189552
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reagent Module
• Version Model Number: 7101-0000
• Catalog Number: 7101-0000
• 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	00386100002664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021515

FDA Product Code

• JFP: Electrode, Ion Specific, Calcium

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: 2019-01-07
• Device Publish Date: 2018-12-05

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• 00386100001797 - Chemistry HbA1c Calibrator Kit: 2019-03-11 HbA1c Calibrator Kit for use with EasyRA Analyzer
• 00386100001803 - CRP Calibrator Kit: 2019-03-11 CRP Calibrator Kit for use with EasyRA Analyzer
• 00386100001858 - Wash1 Kit: 2019-03-11 Wash1 Kit for use with EasyRA Analyzers
• 00386100001872 - QC Kit, Level A: 2019-03-11 EasyQC Quality Control Kit - Level for use with EasyRA Analyzer