PrepPlus 2 378600

GUDID 15099590638191

COULTER PrepPlus 2

Beckman Coulter, Inc.

Specimen processing instrument IVD, automated
Primary Device ID15099590638191
NIH Device Record Key8dbce4ae-c24d-41eb-9693-2d60563ca6e8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrepPlus 2
Version Model Number378600
Catalog Number378600
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590638191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

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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