CapsoCam Plus 2795

GUDID 00867770000209

Small Bowel Capsule Endoscope

CAPSOVISION, INC.

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• Primary Device ID: 00867770000209
• NIH Device Record Key: b98684c8-c496-465b-86c9-e168d04410e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CapsoCam Plus
• Version Model Number: SV-3
• Catalog Number: 2795
• Company DUNS: 789635740
• Company Name: CAPSOVISION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: 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

• Handling Environment Atmospheric Pressure: Between 59 KiloPascal and 105 KiloPascal
• Handling Environment Atmospheric Pressure: Between 59 KiloPascal and 105 KiloPascal
• Handling Environment Atmospheric Pressure: Between 59 KiloPascal and 105 KiloPascal
• Handling Environment Atmospheric Pressure: Between 59 KiloPascal and 105 KiloPascal
• Handling Environment Atmospheric Pressure: Between 59 KiloPascal and 105 KiloPascal
• Handling Environment Atmospheric Pressure: Between 59 KiloPascal and 105 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867770000209 [Primary]
GS1	08677700002010 [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: 5
• Public Version Date: 2020-02-25
• Device Publish Date: 2018-07-17

On-Brand Devices [CapsoCam Plus]

• 00867770000209: Small Bowel Capsule Endoscope
• 00867770000261: Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit