Flow Set Pro (RUO A69184) A63492

GUDID 15099590205775

Flow-Set Pro Fluorospheres

Beckman Coulter, Inc.

Non-blood cell primer/calibrator/control material IVD, reagent
Primary Device ID15099590205775
NIH Device Record Key20cdd334-59fe-49cf-8c9e-7e2bacbafa18
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlow Set Pro (RUO A69184)
Version Model NumberA63492
Catalog NumberA63492
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590205775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDXFlow Cytometry Calibrator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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