ClearIt Anti-Fog Kit

Basic Information

• Brand Name: ClearIt Anti-Fog Kit
• Primary DI: 10810805000146
• Version / Model: PS003
• Company Name: PRESERVATION SOLUTIONS INC
• Labeler DUNS: 090266979
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-10-11
• Public Version: 4
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: ecf4aac4-332c-4014-a814-50fc193742ab

Device Description

A sterile kit containing a 6cc vial of anti-fog solution and sponge with radiopaque marker, pack of 10

Device Characteristics

• Single Use: Yes
• 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: 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
45225	Endoscope antifog solution	A liquid substance intended to be used to prevent the occurrence of condensed vapour (fog) on the lens of an endoscopic instrument during treatment. It will typically be used on the lens of an endoscopic camera where the warmth from an enclosed body cavity creates the conditions to produce fog on the lens. This device will typically be contained in a spray can, bottle, or squeeze bottle. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20810805000143	GS1		60	In Commercial Distribution
Primary	10810805000146	GS1
Unit of Use	00810805000149	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K022826	000