FDA.reportPublic FDA data

NOVIX

Primary DI
00500223504335
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
Rx
false
OTC
false
Sterile
false
Single use
false

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
216344051
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00040565120270COVRSITE59715100597151002026-01-19
05000223494643PICO66022022660220222018-08-23
05000223494650PICO66022023660220232018-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
30197344042115MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042128MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-23
40197344042129MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-23
10197344042104MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
10197344138906MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
20197344042101MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
20197344138903MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
00500223504328NOVIXSMITH & NEPHEW MEDICAL LIMITEDNEC2026-01-13
00616784345512Durma+ Unna Boot Bandage with Zinc Oxide and Calamine Dynarex CorporationNEC2025-12-18
00616784345611Durma+ Unna Boot Bandage with Zinc Oxide and Calamine Dynarex CorporationNEC2025-12-18
00616784345413Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
00616784345314Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
00616784345437Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
05000223502706No Sting Skin PrepSMITH & NEPHEW MEDICAL LIMITEDNEC2025-11-26