i.Profiler plus 000000-2358-727

GUDID 04250668606755

N/A

Carl Zeiss Vision GmbH

Automated ophthalmic refractometer
Primary Device ID04250668606755
NIH Device Record Key49ff4637-bffc-4423-ae6a-e8238e545439
Commercial Distribution StatusIn Commercial Distribution
Brand Namei.Profiler plus
Version Model Number000000-2358-727
Catalog Number000000-2358-727
Company DUNS333928146
Company NameCarl Zeiss Vision GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com
Phone+1(423)598-2680
Emailjahmal.cannon@zeiss.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 701 millibar
Storage Environment HumidityBetween 0 and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104250668606755 [Primary]

FDA Product Code

HKORefractometer, ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-11
Device Publish Date2021-01-01

On-Brand Devices [i.Profiler plus]

04250668606755N/A
04250668606625N/A

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