Soda Lime for LUMIPULSE System

GUDID 04987270234440

FUJIREBIO INC.

Carbon dioxide absorbent solution IVD

• Primary Device ID: 04987270234440
• NIH Device Record Key: b53d22e9-2e37-4672-87ef-b8e1c045e963
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soda Lime for LUMIPULSE System
• Version Model Number: 234440
• 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: 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: 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: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter
• Width: 1.3 Centimeter
• Length: 6 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270234440 [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: 2020-01-20
• Device Publish Date: 2020-01-10

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