RAPID FGS-0396

GUDID 07290101362265

Access SW kit, v7.0

Given Imaging, Inc.

Video capsule endoscopy system

• Primary Device ID: 07290101362265
• NIH Device Record Key: a92bafdb-8d9e-490a-bdae-85937e47ca4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAPID
• Version Model Number: FGS-0396
• Catalog Number: FGS-0396
• Company DUNS: 090073722
• Company Name: Given Imaging, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290101362265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101250

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [RAPID]

• 07290101365013: SW kit, v8.0 SCA WS
• 07290101365006: SW upgrade, v8.0 SCA
• 07290101364467: WS, Dell T3400, OUS RFB
• 07290101364207: WS, Dell T3400, SCA
• 07290101364184: WS, Dell T3400, US
• 07290101363477: RT SW kit, v8.0 WW
• 07290101362784: Access SW kit, v7.0 WS
• 07290101362265: Access SW kit, v7.0
• 07290101362234: SW upgrade, v7.0