WASH conc. 2 RX3962

GUDID 05055273206043

Cleaning Solution for the RX series analysers

RANDOX LABORATORIES LIMITED

Wash/cleaning solution IVD, automated/semi-automated system

• Primary Device ID: 05055273206043
• NIH Device Record Key: 560dd0de-d1e3-4796-98e3-2307d10c578e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WASH conc. 2
• Version Model Number: RX3962
• Catalog Number: RX3962
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The diluted wash solution is stable for 4 weeks in the absence of contamination when stored at +15°C to +25°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273206043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024014

FDA Product Code

• JJF: Analyzer, Chemistry, Micro, 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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