FDA.report

Medline

Primary DI
40080196693451
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
NONFB100
Catalog number
NONFB100
Device description
KIT,ANTI FOG,W/SPONGE & FLUID,SOFT PACK
Published
2023-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OCTAnti fog solution and accessories, endoscopy

Product Code Classifications

CodeDeviceSpecialtyClass
OCTAnti Fog Solution And Accessories, EndoscopyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196693451PackageGS120In Commercial Distribution
10080196693450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019669345140080196693451
1008019669345010080196693450

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
14714127863150blue endoUNIMAX MEDICAL SYSTEMS INC.OCT2024-06-20
40195327105366Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OCT2023-10-29
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
00412786063870CONMEDUNIMAX MEDICAL SYSTEMS INC.OCT2019-12-17
10326053102629Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OCT2019-10-30
09349967002056AntiFogORTHE O R COMPANY PTY LTDOCT2019-09-25
10849771037856Key Surgical Mr. Clear Anti-FogKEY SURGICAL, INC.OCT2019-07-24
09349967001561Scope HelpOR ProTHE O R COMPANY PTY LTDOCT2019-03-27
10817984011208Richard WolfMECTRA LABS, INC.OCT2019-01-29
20817984010185Mr. Clear PurpleMECTRA LABS, INC.OCT2019-01-28
10817984011215Richard WolfMECTRA LABS, INC.OCT2019-01-28
10817984010133Mr. Clear PurpleMECTRA LABS, INC.OCT2019-01-25
10817984010898Needle Counter BoxMECTRA LABS, INC.OCT2019-01-25
10817984010935Mr. Clear PurpleMECTRA LABS, INC.OCT2019-01-25
10817984011130Mr. Clear PurpleMECTRA LABS, INC.OCT2019-01-25
10817984010195Mr. Clear PurpleMECTRA LABS, INC.OCT2019-01-24
10817984010201Mr. Clear PurpleMECTRA LABS, INC.OCT2019-01-24
20817984010949Mr. Clear PurpleMECTRA LABS, INC.OCT2019-01-24
10817984011123Mr. Clear PurpleMECTRA LABS, INC.OCT2019-01-24
20817984011236VygonMECTRA LABS, INC.OCT2019-01-24
00690521014633Anti-Fog KitBatrik Medical Manufacturing IncOCT2018-06-29
20885403231640V. MuellerCAREFUSION 2200, INCOCT2017-11-09
20787551000799Anti-Fog w/ Pad; PLXODUS MEDICAL, INC.OCT2017-05-02