CapsoAccess 5373

GUDID 00867770000230

Capsule Data Access System

CAPSOVISION, INC.

Video capsule endoscopy system capsule

• Primary Device ID: 00867770000230
• NIH Device Record Key: 41395993-fdb6-43d4-9185-27e34b346d2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CapsoAccess
• Version Model Number: 3
• Catalog Number: 5373
• Company DUNS: 789635740
• Company Name: CAPSOVISION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408.624.1488
• Email: azimun.jamal@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 19 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867770000230 [Primary]
GS1	08677700002034 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161773

FDA Product Code

• NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-25
• Device Publish Date: 2018-07-17

Devices Manufactured by CAPSOVISION, INC.

• 00867770000261 - CapsoCam Plus: 2020-12-21 Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit
• 00867770000254 - CapsoRetrieve: 2020-10-06 Capsule Retrieval Kit Pan
• 00867770000223 - CapsoCloud: 2020-03-10 Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and uploa
• 00867770000209 - CapsoCam Plus: 2020-02-25 Small Bowel Capsule Endoscope
• 00867770000230 - CapsoAccess: 2020-02-25Capsule Data Access System
• 00867770000230 - CapsoAccess: 2020-02-25 Capsule Data Access System
• 00867770000216 - CapsoView: 2020-02-24 Software
• 00867770000247 - CapsoRetrieve: 2020-02-24 Capsule Retrieval Kit