CELOX First Aid

Basic Information

• Brand Name: CELOX First Aid
• Primary DI: 15060206630267
• Version / Model: FG08834321
• Catalog Number: FG08834321
• Company Name: MEDTRADE PRODUCTS LIMITED
• Labeler DUNS: 238476068
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-28
• Public Version: 3
• Public Version Date: 2022-05-20
• Public Version Status: Update
• Public Device Record Key: 1ebd38d0-7b08-4637-ba90-d4da8c802f08

Device Description

Hemostatic Gauze: The device is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions. Hemostatic gauze is for temporary external use only.

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: 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: 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
65341	Chitosan haemostatic agent, home-use	A non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied by a layperson at home to superficial wounds (e.g., minor cuts, lacerations, abrasions) to produce a rapid haemostasis by forming a robust plug of gel which is removed after use; it is not intended for severe wounds/emergency situations. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35060206630261	GS1	Shelf Carton	10	In Commercial Distribution
Primary	15060206630267	GS1
Package	75060206630269	GS1	Shipper Case	100	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Supplied folded size 2in by 2in
Device Size Text, specify			Full dressing size 4in by 4in (10.2cm by 10.2cm)
Length	4	Inch
Width	4	Inch