RetCam Portable

GUDID 00899281002137

The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.

NATUS MEDICAL INC

Ophthalmic fundus camera
Primary Device ID00899281002137
NIH Device Record Key813add49-a1e3-44a4-91f6-b77dd64ba294
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetCam Portable
Version Model NumberRetCam Portable
Company DUNS080517260
Company NameNATUS MEDICAL 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 650-802-0400
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com
Phone9256213222
Emailservice@retcam.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 20.7 Inches of Mercury and 31.3 Inches of Mercury
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100864222000428 [Primary]
GS100899281002137 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKICamera, Ophthalmic, 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 Date2017-12-04

Devices Manufactured by NATUS MEDICAL INC

00899281002113 - RetCam 32018-07-06 RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital
00899281002120 - RetCam Shuttle2018-07-06 The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, ful
00899281002137 - RetCam Portable2018-07-06The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
00899281002137 - RetCam Portable2018-07-06 The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fu

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.