FDA.reportPublic FDA data

NOVIX

Primary DI
00500223504328
Brand
NOVIX
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66027708
Catalog number
66027708
Device description
NOVIX PRIMER AND CLEANSER 4OZ
Published
2026-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00500223504335PackageGS112In Commercial Distribution
00500223504328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00500223504335005002235043355002235043350500223504335
00500223504328005002235043285002235043280500223504328

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Special Storage Conditions being 25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
216344051
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05000223504328NOVIX66027708660277082026-01-13
05000223503284ACTICOAT Flex66027689660276892026-08-25
05000223503697ACTICOAT Flex66027691660276912026-08-25
05000223482589CICA CARE66801491668014912026-04-30
05000223502157CICA CARE66803184668031842026-04-30
05000223502270ACTICOAT Flex66027686660276862026-04-29
05000223502300ACTICOAT Flex66027687660276872026-04-29
05000223502331ACTICOAT Flex66027688660276882026-04-29
05000223502249ACTICOAT Flex66027685660276852026-04-28
05000223502218ACTICOAT FLEX66027684660276842026-03-26
05000223503727ACTICOAT Flex66027683660276832026-03-26
05000223503956LEAF66807739668077392026-03-03
05000223503994LEAF66807745668077452026-03-01
00040565117737COVRSITE5971430059714300 / 597144002026-01-19
00040565117690COVRSITE5971400059714000 / 597141002026-01-19
00040565120249COVRSITE59715000597150002026-01-19
00040565120263COVRSITE59715100597151002026-01-19
00040565117706COVRSITE5971400059714000 / 597141002026-01-19
00040565117744COVRSITE5971430059714300 / 597144002026-01-19
00040565120256COVRSITE59715000597150002026-01-19

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