Zorflex

Basic Information

• Brand Name: Zorflex
• Primary DI: 05060467570138
• Version / Model: ZF10
• Catalog Number: ZF10
• Company Name: CHEMVIRON CARBON LIMITED
• Labeler DUNS: 399080118
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-01
• Public Version: 1
• Public Version Date: 2021-09-09
• Public Version Status: New
• Public Device Record Key: f262fa4e-bb59-46d2-91bd-1cd4d7ecd4a4

Device Description

Odor adsorbing medical dressing consisting of cut pieces of activated carbon cloth

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47475	Odour-absorbent dressing, antimicrobial	A pad covering for malodourous wounds or lesions (e.g., venous leg ulcers, fungating carcinomas, infected surgical wounds), that absorbs the bad odours typically through a layer of activated charcoal, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. Given the types of wounds to which it is typically applied, the device may also contain a layer that absorbs heavy exudates, and one that minimizes adherence to the wound. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060467570008	GS1	Carton	10	In Commercial Distribution
Primary	05060467570138	GS1
Package	05060467570091	GS1	Box	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	10	Centimeter
Width	10	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry