Aer-O-Scope Water Bottle

Basic Information

• Brand Name: Aer-O-Scope Water Bottle
• Primary DI: 07290016992038
• Version / Model: Rev A
• Catalog Number: MASA02474
• Company Name: G.I. VIEW LTD
• Labeler DUNS: 533751681
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-01
• Public Version: 3
• Public Version Date: 2019-02-21
• Public Version Status: Update
• Public Device Record Key: 0ff94558-2fb8-4031-9d5d-d655c2907662

Device Description

Water bottle and cap to be used exclusively with the Aer-O-Scope Colonoscope System

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: Yes
• 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
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62159	Flexible video colonoscope, single-use	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy typically to examine the colon (e.g., diseases on the colon) or colon contents (e.g., blood in stools). It may be designed to be manually inserted or designed with features to assist/power insertion (e.g., push/pull double-balloons, powered propelling mechanism). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290016992035	GS1	box	2	In Commercial Distribution
Primary	07290016992038	GS1

Customer Contacts

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