Soda Lime for LUMIPULSE System

Basic Information

• Brand Name: Soda Lime for LUMIPULSE System
• Primary DI: 04987270234440
• Version / Model: 234440
• Company Name: FUJIREBIO INC.
• Labeler DUNS: 710873907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-10
• Public Version: 1
• Public Version Date: 2020-01-20
• Public Version Status: New
• Public Device Record Key: b53d22e9-2e37-4672-87ef-b8e1c045e963

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
64621	Carbon dioxide absorbent solution IVD	An absorbent solution (e.g., soda lime) with a high affinity for carbon dioxide (CO2) intended to be used to remove carbon dioxide produced through reactions performed onboard an instrument/analyser, to prevent deterioration of assay reagents and/or solutions. It may contain a colour indicator to signal need for replacement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987270234440	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	1.3	Centimeter
Length	6	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: High humidity 80%RH; Indoor, avoid direct sunlight; Non-condensing
• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius