FDA UDI
In Commercial Distribution
🇺🇸 United States
Provox Cleaning Towel
DI: 07331791015762
·
Model: 7244
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Provox Cleaning Towel
- Primary DI
- 07331791015762
- Version / Model
- 7244
- Catalog Number
- 7244
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 1
- Public Version Date
- 2022-12-02
- Public Version Status
- New
- Public Device Record Key
- 7ac39aca-e7ab-459f-9d5c-d399c8188a8a
Device Description
Provox Cleaning Towel is intended for cleaning around the stoma, it will remove oil from the skin. They are indented to use before application of Provox Adhesives.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOX | Solvent, Adhesive Tape | General, Plastic Surgery | 878.4730 | 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 | 07331791001536 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 07331791015762 | GS1 | ||||
| Unit of Use | 07331791016400 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 42 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight