CapsoAccess 5373

GUDID 00867770000230

Capsule Data Access System

CAPSOVISION, INC.

Video capsule endoscopy system capsule
Primary Device ID00867770000230
NIH Device Record Key41395993-fdb6-43d4-9185-27e34b346d2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapsoAccess
Version Model Number3
Catalog Number5373
Company DUNS789635740
Company NameCAPSOVISION, 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 Batchtrue
Serial Numberfalse
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

Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408.624.1488
Emailazimun.jamal@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com
Phone408-624-1488
Emailinfo@capsovision.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100867770000230 [Primary]
GS108677700002034 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-02-25
Device Publish Date2018-07-17

Devices Manufactured by CAPSOVISION, INC.

00867770000261 - CapsoCam Plus2020-12-21 Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit
00867770000254 - CapsoRetrieve2020-10-06 Capsule Retrieval Kit Pan
00867770000223 - CapsoCloud2020-03-10 Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and uploa
00867770000209 - CapsoCam Plus2020-02-25 Small Bowel Capsule Endoscope
00867770000230 - CapsoAccess2020-02-25Capsule Data Access System
00867770000230 - CapsoAccess2020-02-25 Capsule Data Access System
00867770000216 - CapsoView2020-02-24 Software
00867770000247 - CapsoRetrieve2020-02-24 Capsule Retrieval Kit

Trademark Results [CapsoAccess]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPSOACCESS
CAPSOACCESS
86655577 4976535 Live/Registered
CapsoVision, Inc.
2015-06-09
CAPSOACCESS
CAPSOACCESS
86068757 4633850 Live/Registered
CapsoVision, Inc.
2013-09-18

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