Phoenix Diagnostics 19-007

GUDID 00853366007608

Universal Cal Pack (Snap Pack) for Medica EasyLyte Series Electrolyte Systems

PHOENIX DIAGNOSTICS, INC.

Multiple electrolyte IVD, calibrator

• Primary Device ID: 00853366007608
• NIH Device Record Key: db053e70-099e-4455-9996-d6cb9282f5bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phoenix Diagnostics
• Version Model Number: 19-007
• Catalog Number: 19-007
• Company DUNS: 606814960
• Company Name: PHOENIX DIAGNOSTICS, INC.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5086558310
• Email: sales@phoenixdiagnostics.com

Device Dimensions

• Total Volume: 1080 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853366007608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012987

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-30
• Device Publish Date: 2017-08-12

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