CapsoView 2759

GUDID 00867770000216

Software

CAPSOVISION, INC.

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• Primary Device ID: 00867770000216
• NIH Device Record Key: 58fb39ca-28c0-4179-bd16-9ba7842408cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CapsoView
• Version Model Number: 3
• Catalog Number: 2759
• 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
• Phone: 408-624-1488
• Email: info@capsovision.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867770000216 [Primary]
GS1	08677700002027 [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: 4
• Public Version Date: 2020-02-24
• 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: 2020-02-25 Capsule Data Access System
• 00867770000216 - CapsoView: 2020-02-24Software
• 00867770000216 - CapsoView: 2020-02-24 Software
• 00867770000247 - CapsoRetrieve: 2020-02-24 Capsule Retrieval Kit