SmartPill 50100600

GUDID 04260167482903

activation fixture

Covidien LP

Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system

• Primary Device ID: 04260167482903
• NIH Device Record Key: 91579042-49a7-41ea-8eb1-3d0c420b42f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartPill
• Version Model Number: 50100600
• Catalog Number: 50100600
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: 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: +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
• 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
• 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	04260167482903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092342

FDA Product Code

• NYV: gastrointestinal motility system, 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: 2017-02-13

On-Brand Devices [SmartPill]

• 07290101367390: Smartbar
• 04260167483573: recorder, RFB
• 04260167482903: activation fixture
• 04260167482897: docking station kit
• 04260167482880: recorder kit
• 04260167482873: MotiliGI notebook kit
• 04260167482712: capsule, single
• 04260167482705: SmartBar, 5-pack
• 04260167482682: capsule, 5-pack
• 07290110360481: SmartPill software v3.1