NaviCam Small Bowel Capsule Endoscopy System

Basic Information

• Brand Name: NaviCam Small Bowel Capsule Endoscopy System
• Primary DI: 06921010800524
• Version / Model: Recorder/AKRI-1
• Catalog Number: SB-US-2003
• Company Name: ANKON Technologies Co.,Ltd.
• Labeler DUNS: 549329633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-27
• Public Version: 2
• Public Version Date: 2024-01-01
• Public Version Status: Update
• Public Device Record Key: 78cf1560-2e51-4be9-8ff0-477cd84b3247

Device Description

It is used for receiving image data wirelessly transmitted from the Capsule.

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	876.1300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64665	Video capsule endoscopy monitoring kit	A collection of noninvasive devices intended to assist with the monitoring of image data from an ingested video capsule (not included), as it passes through the gastrointestinal (GI) tract. It typically consists of a monitor, an antenna that receives the wireless signals from the capsule, and additional devices utilized for the recording procedure (e.g., connection cables, holders, protectors); it may in addition include a capsule activator(s). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06921010800524	GS1

Customer Contacts

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