FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 20885380182850
·
Model: ZA40075
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
75
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 20885380182850
- Version / Model
- ZA40075
- Catalog Number
- ZA40075
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2022-07-08
- Public Version
- 2
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- be13f341-161e-469d-b6df-4b7d777fdf85
Device Description
Protective Barrier Wipe Protects skin for Adhesives, Incontinence, and Bodily Fluids Non-irritating to Intact Skin Thick, Soft Application Pad Instructions: Apply to clean, dry skin. Allow to air dry. Do not use on open wounds. Warning: For external use only. Single use only. Do not use with electrocautery procedures. Stinging may result from contact. Not made with natural rubber latex. Ingredients: Isopropyl alcohol, water, ethyl ester of PVM/MA copolymer, ethyl alcohol, acetyl tributyl citrate
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
- Yes
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| KOX | SOLVENT, ADHESIVE TAPE | General, Plastic Surgery | 878.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58978 | Synthetic-polymer liquid barrier dressing | A liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. 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 | 50885380182851 | GS1 | CASE | 16 | In Commercial Distribution | |
| Primary | 20885380182850 | GS1 | ||||
| Unit of Use | 10885380182853 | GS1 |