SOLN WASH RX4003

GUDID 05055273210361

This should be run once a day to prevent protein build up or at 8 hour intervals if the ISE module performs more than 50 samples per day. Cleaning so

RANDOX LABORATORIES LIMITED

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

• Primary Device ID: 05055273210361
• NIH Device Record Key: 8efa8de0-447c-4731-b719-7f8e4100f118
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLN WASH
• Version Model Number: RX4003
• Catalog Number: RX4003
• 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
• 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 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273210361 [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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