PHOENIX DIAGNOSTICS, INC.

GUDID 00853366007691

Flame Standard 140/5 for I.L. 943

PHOENIX DIAGNOSTICS, INC.

Multiple electrolyte IVD, calibrator

• Primary Device ID: 00853366007691
• NIH Device Record Key: 93589674-2347-4b24-9c60-95528dfdb00a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHOENIX DIAGNOSTICS, INC.
• Version Model Number: 13-005
• Company DUNS: 606814960
• Company Name: PHOENIX DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Total Volume: 60 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853366007691 [Primary]
GS1	10853366007698 [Package]; Package: [30 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2020-03-30
• Device Publish Date: 2018-01-25

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• 00853366007271: ISE Compensator for Roche / Hitachi Chemistry Systems
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• 10853366007254: Cell Clean 90, 1N NaOH for Roche / Hitachi Chemistry Systems
• 10853366007230: Hitergent for Roche / Hitachi 700 Series
• 10853366007209: ISE 1N KCL Sol for Roche / Hitachi 911 Series Chemistry Systems
• 00853366007189: ISE Internal Ref Sol for Roche / Hitachi 911 Series Chemistry Systems
• 00853366007165: ISE Diluent for Roche / Hitachi 911 Series Chemistry Systems
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• 00853366007134: Reference Electrode for Olympus AU Series Chemistry Systems
• 00853366007127: Cl- Electrode for Olympus AU Series Chemistry Systems
• 00853366007110: K+ Electrode for Olympus AU Series Chemistry Systems
• 00853366007103: Na+ Electrode for Olympus AU Series Chemistry Systems
• 10853366007094: Cleaning Solution for Olympus AU Series Chemistry Systems
• 10853366007087: ISE Na+ and K+ Selectivity Check Solutions for Olympus AU Series Chemistry Systems
• 10853366007070: ISE Internal Reference Fill Solution for Olympus AU Series Chemistry Systems
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