FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 00888499001346
·
Model: WC8OZ
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
8
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 00888499001346
- Version / Model
- WC8OZ
- Catalog Number
- WC8OZ
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2019-05-16
- Public Version
- 2
- Public Version Date
- 2024-01-25
- Public Version Status
- Update
- Public Device Record Key
- 47015e04-1b1a-4a5f-8ffa-736090823755
- Distribution End Date
- 2025-11-21
Device Description
Wound Cleanser No-rinse, non-irritating formulation Non-ionic surfactant Directions for use: 1. Turn nozzle to stream or spray position. 2. Spray contents on area to be cleansed approximately 3 inches away. Ingredients: Purified water, poloxamer 188, sodium bicarbonate, sorbitol, citric acid, disodium EDTA, methylparaben, imidazolidinyl urea Indications: May be used for the removal of foreign materials such as dirt and debris from dermal wounds. Caution: For external use only. Keep this and all similar products out of the reach of children. Store at ambient temperature.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, wound, drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47156 | Skin detergent | A non-dedicated chemical solution intended to be applied to the surface of the skin for cleaning and/or conditioning, and is commonly used to remove dirt, debris, peeling skin, and/or for the attenuation of minor skin disorders (e.g., dry skin). It contains a synthetic surfactant (e.g., sodium laureth sulfate) and is normally available [non-prescription] over-the-counter (OTC) for home-use. 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 | 10888499001343 | GS1 | CASE | 12 | In Commercial Distribution | 2025-11-20 |
| Primary | 00888499001346 | GS1 | ||||
| Unit of Use | 00885380171867 | GS1 |