FDA.reportPublic FDA data

ClearIt Anti-Fog Kit

Primary DI
10810805000146
Brand
ClearIt Anti-Fog Kit
Company
PRESERVATION SOLUTIONS INC
Model
PS003
Device description
A sterile kit containing a 6cc vial of anti-fog solution and sponge with radiopaque marker, pack of 10
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCTAnti Fog Solution And Accessories, Endoscopy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCTAnti Fog Solution And Accessories, EndoscopyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022826000CLEAR-IT ANTI-FOG, MODEL PS003Preservation Solutions, Inc.2002-10-09OCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810805000143PackageGS160In Commercial Distribution
10810805000146PrimaryGS10
00810805000149Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081080500014320810805000143
1081080500014610810805000146
00810805000149008108050001498108050001490810805000149

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope antifog solutionA 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.

Contacts#

Phone, Email table
PhoneEmail
2627236715brader@preservationsolutions.com

Regulatory Flags#

DUNS number
090266979
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810805000139ClearIt Anti-Fog ClothPS0012016-10-22
00810805000026Belzer UW Cold Storage Solution BUW-5002016-10-22
00810805000040Belzer UW Cold Storage Solution BUW-0012016-10-07
00810805000071Belzer UW Cold Storage SolutionBUW-0022016-10-22
00810805000095Belzer MPS (UW Machine Perfusion Solution )MPS-0012016-10-22
00810805000101Belzer MPS (UW Machine Perfusion Solution )BTLBMPS-10002017-04-03
00810805000156Waters IGL Cold Storage SolutionCSS/1000/US2016-10-22
00810805000163Waters IGL Cold Storage SolutionCSS/2000/US2016-10-22
00810805000170Waters IGL Pulsatile Perfusion SolutionPPS/1000/US2016-10-22
10810805000214"Retention Guard Suture Retention Plates - 3"""RG-32018-12-07
00810805000224"StarGuard Suture Retention Plates - 7"""SG-72018-12-07
00810805000231"StarGuard Suture Retention Plates - 9"""SG-92018-12-07
10810805000092Belzer MPS (UW Machine Perfusion Solution )MPS-0012016-10-22
10810805000108Belzer MPS (UW Machine Perfusion Solution )BTLBMPS-10002017-04-03
10810805000177Waters IGL Pulsatile Perfusion SolutionPPS/1000/US2016-10-22
00810805000187Wittmann PatchEWP20402016-10-22
00810805000194XTACXTAC2016-10-22
10810805000023Belzer UW Cold Storage Solution BUW-5002016-10-22
10810805000047Belzer UW Cold Storage Solution BUW-0012016-10-07
10810805000078Belzer UW Cold Storage SolutionBUW-0022016-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
27290019426053Plasma ShieldPlasmatica Ltd.OCT2025-12-15
04714127863153blue endoUNIMAX MEDICAL SYSTEMS INC.OCT2024-06-20
14714127863150blue endoUNIMAX MEDICAL SYSTEMS INC.OCT2024-06-20
10195327105365Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OCT2023-10-29
40195327105366Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OCT2023-10-29
10080196693450MedlineMEDLINE INDUSTRIES, INC.OCT2023-10-13
40080196693451MedlineMEDLINE INDUSTRIES, INC.OCT2023-10-13
27290019426008Plasma ShieldPlasmatica Ltd.OCT2023-05-17
27290019426022Plasma ShieldPlasmatica Ltd.OCT2023-05-17
00840113200597Dr. Fog® Solution With SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200627Dr. Fog® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200863Aspen® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206896Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206926Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113214105Leonhard Lang/Fannin Anti-Fog Kit; SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200580Dr. Fog® Solution With SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200603Dr. Fog® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200870Aspen® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206902Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206957Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113214099Leonhard Lang/Fannin Anti-Fog Kit; SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113214822Medline Anti-Fog, SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113230433ArcRoyal Anti-Fog, Regular Solution, SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
04714127860893CONMEDUNIMAX MEDICAL SYSTEMS INC.OCT2019-12-17
20326053102626Regard™Resource Optimization & Innovation, L.L.C.OCT2019-10-30
10326053102629Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OCT2019-10-30
09349967002032AntiFogORTHE O R COMPANY PTY LTDOCT2019-09-25
09349967002056AntiFogORTHE O R COMPANY PTY LTDOCT2019-09-25
10885380166204CARDINAL HEALTHCardinal Health 200, LLCOCT2019-08-08
00849771037859Key Surgical Mr. Clear Anti-FogKEY SURGICAL, INC.OCT2019-07-24