i.Terminal 2 000000-1898-991

GUDID 04250668606694

N/A

Carl Zeiss Vision GmbH

Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter Ophthalmodiastimeter
Primary Device ID04250668606694
NIH Device Record Keyf1a03a0e-16a0-45ad-a8ce-4e943b78248f
Commercial Distribution StatusIn Commercial Distribution
Brand Namei.Terminal 2
Version Model Number000000-1898-991
Catalog Number000000-1898-991
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

Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 and 795 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 and 795 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104250668606694 [Primary]

FDA Product Code

HMMDistometer

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.Terminal 2]

04250668606694N/A
04250668606717N/A

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