H SOLN RX4046

GUDID 05055273214345

Used as a Calibrator in a two-point calibration. H Solution is aspirated from a sample cup located in a pre-registered position on the sample carousel

RANDOX LABORATORIES LIMITED

Multiple clinical chemistry analyte IVD, calibrator

• Primary Device ID: 05055273214345
• NIH Device Record Key: 433b6e69-694e-4dd8-9b0d-0709977083ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H SOLN
• Version Model Number: RX4046
• Catalog Number: RX4046
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened H Solution is stable for 1 month at +15 to +25°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273214345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131554

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2018-07-06
• Device Publish Date: 2016-09-26

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