FDA.reportPublic FDA data

SEA-CLENS

Primary DI
00311701159356
Brand
SEA-CLENS
Company
Coloplast A/S
Model
1061
Catalog number
1061
Device description
No-Rinse Cleanser
Published
2022-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NECBandage, liquid, skin protectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NECBandage, Liquid, Skin ProtectantGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00311701159554PackageGS112In Commercial Distribution
00311701159356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00311701159554003117011595543117011595540311701159554
00311701159356003117011593563117011593560311701159356

GMDN Terms#

Term, Definition table
TermDefinition
Secretion/excreta skin cleanserA non-sterile substance typically used by ostomists or incontinent persons to gently cleanse skin exposed to intestinal secretions (e.g., around a stoma or fistula) or to excreta (urine or faeces). It is typically used to replace cleaning with soap and water which can aggravate the skin causing soreness/inflammation; it may also be used to remove small amounts of adhesive residue or barrier creams. The device is provided in a variety of forms including a solution, sachets, or disposable wipes. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume12Fluid Ounce
Total Volume355Milliliter

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932588942Freedom Clear5057415057412022-12-06
05708932957847Freedom Clear5057315057312022-12-06
05708932125338SpeediCath Flex Coude Pro20012200122019-07-12
05708932125369SpeediCath Flex Coude Pro20014200142019-07-12
05701780348317Luja Soft20171201712026-10-01
05701780348348Luja Soft20172201722026-10-01
05701780348379Luja Soft20174201742026-10-01
05701780348409Luja Soft20176201762026-10-01
05701780265058Biatain Adhesive348834882026-08-27
05708932787109Titan PrimeDS3918DS39182026-08-14
05708932787116Titan PrimeDS3920DS39202026-08-14
05708932787123Titan PrimeDS3922DS39222026-08-14
05708932787130Titan Prime5400055400052026-08-14
05708932787147Titan Prime5400105400102026-08-14
05708932787888Titan Prime5400155400152026-08-14
05708932787925Titan Prime5400205400202026-08-14
05708932787963Titan Prime5400255400252026-08-14
05708932788007Titan Prime5400305400302026-08-14
05708932788045Titan Prime5400405400402026-08-14
05708932788083Titan Prime5400505400502026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850002835212Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835229Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835304Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835533Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835540Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835632Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835649Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007422Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007439Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007583Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007590Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007606Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007613Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00852927004001Respiratory AccessorySunset Healthcare Solutions, Inc.NEC2026-09-09
16958868743069BiokerzonRoosin Medical Co., Ltd.NEC2026-04-27
08904428721399OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428721405OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745326OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745333OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
10885632460296HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460302HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460319HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460326HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460290HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
20885632460309HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460313HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460320HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10197344042098MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042111MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
20197344042095MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26