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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270234440 [Primary]

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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