Lumipulse G Dilution Cartridges

GUDID 04987270230466

FUJIREBIO INC.

Laboratory analyser cuvette IVD, single-use

• Primary Device ID: 04987270230466
• NIH Device Record Key: 287496ef-cbc1-434e-a65b-ac28c5d3405e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse G Dilution Cartridges
• Version Model Number: 230466
• Company DUNS: 710873907
• Company Name: FUJIREBIO INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com

Device Dimensions

• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter
• Height: 4 Centimeter
• Width: 18.5 Centimeter
• Length: 11.5 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Non-condensing
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270230466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142895

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-27

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