Pure&Clean

Basic Information

• Brand Name: Pure&Clean
• Primary DI: 00852421007867
• Version / Model: 2025.11
• Company Name: Pure & Clean, LLC
• Labeler DUNS: 045315650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-12
• Public Version: 1
• Public Version Date: 2025-12-22
• Public Version Status: New
• Public Device Record Key: 7fbb0574-477c-44f8-8520-2756b8135b18

Device Description

Pure&Clean Antimicrobial WoundGel Professional, 3 fl oz (89 ml)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, 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 and gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852421007867	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	3	Fluid Ounce

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 0 – Degrees Celsius