Park 1

GUDID 04049584000217

The PARK 1 combines three measuring functions in one unit. Auto-Refractometer An infrared light source projects measuring light onto the retina of the

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Ophthalmic refractometer, manual
Primary Device ID04049584000217
NIH Device Record Keya40ea847-b377-47c1-978d-43101bcca848
Commercial Distribution StatusIn Commercial Distribution
Brand NamePark 1
Version Model Number65000
Company DUNS317138956
Company NameOCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
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 Datefalse
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Weight12 Kilogram
Depth530 Millimeter
Width538 Millimeter
Height265 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104049584000217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLQKeratoscope, Ac-Powered

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 Date2016-09-01

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

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04049584001450 - BK 1/W, coated, wall version, trial lens case2024-09-12 BK 1/W, coated, wall version, trial lens case
04049584001467 - BK 1/W, without convex cylinders, wall version, trial lens case2024-09-12 BK 1/W, without convex cylinders, wall version, trial lens case
04049584001474 - BK 1/W, without convex cylinders, coated, wall version, trial lens case2024-09-12 BK 1/W, without convex cylinders, coated, wall version, trial lens case
04049584001498 - BK 2, coated, wooden case with handle2024-09-12 BK 2, coated, wooden case with handle
04049584001511 - BK 2, without convex cylinders, wooden case with handle2024-09-12 BK 2, without convex cylinders, wooden case with handle
04049584001528 - BK 2, without convex cylinders, coated,wooden case with handle2024-09-12 BK 2, without convex cylinders, coated,wooden case with handle

Trademark Results [Park 1]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PARK 1
PARK 1
77322466 3709312 Live/Registered
Oculus Optikgeraete GmbH
2007-11-06

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