L SOLN D400-0018

GUDID 05055273214888

Used as a Calibrator in a two-point calibration. L Solution is pumped into the sample port by the L Solution pump and then positioned in front of the

RANDOX LABORATORIES LIMITED

Multiple clinical chemistry analyte IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator

• Primary Device ID: 05055273214888
• NIH Device Record Key: f62183a9-89a8-410f-a1d8-b01dc46fd3ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L SOLN
• Version Model Number: D400-0018
• Catalog Number: D400-0018
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273214888 [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

On-Brand Devices [L SOLN]

• 05055273214888: Used as a Calibrator in a two-point calibration. L Solution is pumped into the sample port by th
• 05055273214321: Used as a Calibrator in a two-point calibration. L Solution is pumped into the sample port by th