SmartPill

Basic Information

• Brand Name: SmartPill
• Primary DI: 04260167482682
• Version / Model: FGS-0503
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-02-13
• Public Version: 7
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: ce0040e6-5a7f-4a05-8e35-ebc399141c8e

Device Description

capsule, 5-pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NYV	gastrointestinal motility system, capsule	Gastroenterology, Urology	876.1725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58357	Gastrointestinal telemetric monitoring system	An assembly of devices designed to continuously measure and transmit signals for one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from a patient to a receiving location for viewing. It consists of a battery-powered capsule swallowed by the patient, and a patient-worn or clinician-held unit designed to wirelessly receive data from the capsule to either transmit it (i.e., a transceiver) to a computing device or to display it (e.g., a receiver); various solutions/containers may also be included. It is intended to help diagnose gastric pH disorders and/or measure gastrointestinal transit times to evaluate motility disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260167482682	GS1
Unit of Use	10884521726147	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092342	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius