AED ENDOPRO-CAM®

Basic Information

• Brand Name: AED ENDOPRO-CAM®
• Primary DI: 00848657068192
• Version / Model: EP2000
• Catalog Number: EP2000
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• Labeler DUNS: 839138955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-04
• Public Version: 1
• Public Version Date: 2020-03-12
• Public Version Status: New
• Public Device Record Key: 40a8a1d4-a9a8-43f7-b7be-815965c17b0a

Device Description

AED ENDOPRO-CAM® ELITE Portable HD Endoscopic Video System: An electro-optical device (e.g., with an image sensor chip) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. This device includes a camera stand and rechargeable battery.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
FWD	Camera, Television, Microsurgical, Without Audio	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35958	Endoscope video camera	An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848657068192	GS1

Customer Contacts

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