CVS Health

Basic Information

• Brand Name: CVS Health
• Primary DI: 00050428277447
• Version / Model: 832833
• Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
• Labeler DUNS: 062312574
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2020-02-28
• Public Version: 1
• Public Version Date: 2020-03-09
• Public Version Status: New
• Public Device Record Key: f2a52aa1-1d1f-4728-b4a4-222338fb9af9

Device Description

Hydrogel Burn Pads, all one size, 1.96 IN x 2.95 IN (49 mm x 74 mm)

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47763	Wound hydrogel dressing, non-sterile	A non-sterile wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids/gases. Some types are intended to reduce hypertrophic/keloid scars by providing a barrier impermeable to liquids/gases to maintain a moist environment. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20050428277441	GS1	case	72	In Commercial Distribution
Primary	00050428277447	GS1
Unit of Use	60050428277449	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]