PK7300 N3209000

GUDID 14987666535721

PK7300

Beckman Coulter, Inc.

Blood group/antibody screening analyser IVD, automated
Primary Device ID14987666535721
NIH Device Record Keye8386ffe-003b-4d96-8e65-2dad9fceb7b3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePK7300
Version Model NumberN3209000
Catalog NumberN3209000
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
GS114987666535721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSZSystem, Test, Automated Blood Grouping And Antibody

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 Date2016-09-24

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