Lumipulse G Dilution Cartridges

GUDID 04987270230466

FUJIREBIO INC.

Laboratory analyser cuvette IVD, single-use
Primary Device ID04987270230466
NIH Device Record Key287496ef-cbc1-434e-a65b-ac28c5d3405e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumipulse G Dilution Cartridges
Version Model Number230466
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 Datetrue
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

Length11.5 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987270230466 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-06
Device Publish Date2019-12-27

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