Curativa Bay

Basic Information

• Brand Name: Curativa Bay
• Primary DI: 00860007709470
• Version / Model: WCHRX8
• Company Name: Curativa Bay, LLC
• Labeler DUNS: 016206368
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-26
• Public Version: 1
• Public Version Date: 2026-04-03
• Public Version Status: New
• Public Device Record Key: 222ec74d-81f1-4977-8e4c-d6f6af3d9bf1

Device Description

Rx INDICATIONS: The Prescription Use Curative Bay Wound Care Hydrogel Rx is indicated for the following uses: • Use with dermal irritation, sores, injuries and ulcers of dermal tissues. • Moistening and lubricating absorbent wound dressings and the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. • Management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
59523	Antimicrobial wound irrigation solution	A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007709470	GS1