Power Processor PowerCel A36587

GUDID 15099590604479

Power Processor PowerCel

Beckman Coulter, Inc.

Specimen processing instrument IVD, automated
Primary Device ID15099590604479
NIH Device Record Keyb01ec5d8-121f-4756-83c4-d8fe9e88b897
Commercial Distribution StatusIn Commercial Distribution
Brand NamePower Processor PowerCel
Version Model NumberPower Processor PowerCel
Catalog NumberA36587
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com
Phone(800) 854-3633
Emailxx@xx.com

Operating and Storage Conditions

Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590604479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

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 Date2016-08-15

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