FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380009020
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CF-1001
Catalog number
CF-1001
Device description
Anti-Fog Solution W/Foam Pad
Published
2016-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K932449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932449000DR. FOGO.R. Concepts, Inc.1993-08-11OCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380009028PackageGS120Not in Commercial Distribution
10885380009020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538000902850885380009028
1088538000902010885380009020

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

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