ActiFog™

Basic Information

• Brand Name: ActiFog™
• Primary DI: 10809160022757
• Version / Model: 6505
• Company Name: MEDICAL ACTION INDUSTRIES INC.
• Labeler DUNS: 092364462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f413a619-c546-40b6-8618-f8c3242d01da

Device Description

Solution: Actifog w/Foam Pad 48/Cs

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCT	Anti fog solution and accessories, endoscopy	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45673	Endoscope cleaning kit	A collection of devices and supplies intended for performing manual cleaning of endoscopes. Items include brushes of several sizes, detergents, and applicators. This manual cleaning is typically performed before endoscope sterilization. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160022754	GS1		48	In Commercial Distribution
Primary	10809160022757	GS1

Premarket Submissions

Submission Number	Supplement Number
K932449	000