FDA UDI
In Commercial Distribution
🇺🇸 United States
SEA-CLENS
DI: 00311701159363
·
Model: 1063
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SEA-CLENS
- Primary DI
- 00311701159363
- Version / Model
- 1063
- Catalog Number
- 1063
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-22
- Public Version
- 3
- Public Version Date
- 2024-01-17
- Public Version Status
- Update
- Public Device Record Key
- 9da3899d-d72a-4ed9-9efe-88026a1a559b
Device Description
No-rinse cleanser
Device Characteristics
- Single Use
- No
- 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
- 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
- Yes
- 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 | 00311701159561 | GS1 | Shipper Box | 12 | In Commercial Distribution | |
| Primary | 00311701159363 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 6 | Fluid Ounce | |
| Total Volume | 178 | Milliliter |