FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CVS Health
DI: 00050428327968
·
Model: 984301
·
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
8
Basic Information
- Brand Name
- CVS Health
- Primary DI
- 00050428327968
- Version / Model
- 984301
- Company Name
- WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Labeler DUNS
- 062312574
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2020-09-07
- Public Version
- 2
- Public Version Date
- 2021-01-07
- Public Version Status
- Update
- Public Device Record Key
- bc9accff-51a4-4630-9b9c-2c9dcce0252e
- Distribution End Date
- 2020-09-25
Device Description
Sterile Antibacterial Non-Stick Pads, 3 IN x 4 IN (7.6 cm x 10.1 cm). Contains: Polyhexamethylene Biguanide (PHMB) 0.2%
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 47042 | Wound-nonadherent dressing, absorbent, antimicrobial | A wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20050428327962 | GS1 | case | 72 | Not in Commercial Distribution | 2020-09-25 |
| Primary | 00050428327968 | GS1 | ||||
| Unit of Use | 60050428327960 | GS1 |
Customer Contacts
- Phone
- 18007467287
- [email protected]