Soda Lime for LUMIPULSE System

GUDID 04987270234440

FUJIREBIO INC.

Carbon dioxide absorbent solution IVD
Primary Device ID04987270234440
NIH Device Record Keyb53d22e9-2e37-4672-87ef-b8e1c045e963
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoda Lime for LUMIPULSE System
Version Model Number234440
Company DUNS710873907
Company NameFUJIREBIO INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone610-240-3800
Emailcustomersupport@fdi.com

Device Dimensions

Length6 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987270234440 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-20
Device Publish Date2020-01-10

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