Air Assist

Basic Information

• Brand Name: Air Assist
• Primary DI: 00860012876808
• Version / Model: 1
• Company Name: GASTRO CONCEPTS LLC
• Labeler DUNS: 119470806
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-17
• Public Version: 1
• Public Version Date: 2025-03-25
• Public Version Status: New
• Public Device Record Key: 0371961d-7140-48a1-8b3d-a0edc9924adf

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FER	Anoscope And Accessories	Gastroenterology, Urology	876.1500	2
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60911	Colonoscope distal anchoring cuff	A device in the form of a cuff with concentric finger-like components intended to fit to a flexible colonoscope distal end to stabilize its tip within the colonic lumen and straighten the colonic folds to facilitate observation and/or surgical instrument use. The fingers are intended to open and grip the colon during pull back (exturbation); the device may in addition have a protruding distal end (spacer) intended to maintain distance between the endoscope tip and structures of interest. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012876808	GS1

Premarket Submissions

Submission Number	Supplement Number
K242668	000