LUMIPULSE G1200

GUDID 04987270234259

FUJIREBIO INC.

Chemiluminescent immunoassay analyser IVD, automated

• Primary Device ID: 04987270234259
• NIH Device Record Key: 0762649c-803c-4dd2-87eb-33914a5c51ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIPULSE G1200
• Version Model Number: 234259
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com

Device Dimensions

• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter
• Height: 145 Centimeter
• Width: 120 Centimeter
• Length: 80 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Low Humidity 10%RH; High Humidity 90%RH; Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270234259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142895

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: 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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