COULTER 4C Plus 7547114

GUDID 15099590225216

COULTER 4C Plus Cell Control

Beckman Coulter, Inc.

Full blood count IVD, control
Primary Device ID15099590225216
NIH Device Record Key0482d0b1-45f3-4a11-a7ce-85444b12ba53
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOULTER 4C Plus
Version Model Number7547114
Catalog Number7547114
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590225216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPKMixture, Hematology Quality Control

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

On-Brand Devices [COULTER 4C Plus]

15099590230302COULTER 4C Plus Cell Control
15099590225216COULTER 4C Plus Cell Control

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