FDA UDI
In Commercial Distribution
🇺🇸 United States
NOVIX
DI: 00500223504328
·
Model: 66027708
·
SMITH & NEPHEW MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NOVIX
- Primary DI
- 00500223504328
- Version / Model
- 66027708
- Catalog Number
- 66027708
- Company Name
- SMITH & NEPHEW MEDICAL LIMITED
- Labeler DUNS
- 216344051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-13
- Public Version
- 1
- Public Version Date
- 2026-01-21
- Public Version Status
- New
- Public Device Record Key
- bcacb56b-580f-4762-b06f-d24ad7f11d57
Device Description
NOVIX PRIMER AND CLEANSER 4OZ
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEC | Bandage, liquid, skin protectant | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46205 | Secretion/excreta skin cleanser | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00500223504335 | GS1 | CAS | 12 | In Commercial Distribution | |
| Primary | 00500223504328 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Special Storage Conditions being 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry