VISUSCREEN 500 VISUSCREEN 500

GUDID 04250668606724

N/A

Carl Zeiss Vision GmbH

Visual acuity projector
Primary Device ID04250668606724
NIH Device Record Keyd4c9aba7-0783-4e28-a425-86ae63c73b7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVISUSCREEN 500
Version Model Number000000-2087-230
Catalog NumberVISUSCREEN 500
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
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

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250668606724 [Primary]

FDA Product Code

HOXChart, visual acuity

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

Devices Manufactured by Carl Zeiss Vision GmbH

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04250668606052 - VISUCORE 500 Refractor2023-06-07
04250668606717 - i.Terminal 22021-02-01 N/A
04250668606618 - VISUCONSULT 5002021-01-11 N/A
04250668606625 - i.Profiler plus2021-01-11 N/A
04250668606632 - ATLAS Review for i. Profiler plus2021-01-11 N/A
04250668606649 - i.Terminal mobile2021-01-11 N/A
04250668606663 - VISUFIT 1000 Platform2021-01-11 N/A

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