CELOX First Aid

Basic Information

• Brand Name: CELOX First Aid
• Primary DI: 15060206630670
• Version / Model: FG08834051
• Catalog Number: FG08834051
• Company Name: MEDTRADE PRODUCTS LIMITED
• Labeler DUNS: 238476068
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 3
• Public Version Date: 2022-05-20
• Public Version Status: Update
• Public Device Record Key: 8a4b7317-36d1-40f8-b657-746c3de0e8c8

Device Description

Hemostatic Gauze: Hemostatic Gauze Pads coated with CELOX granules. Indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

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	75060206630672	GS1	Shipper Case	50	In Commercial Distribution
Primary	15060206630670	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Pad 8in by 8in (20.3cm x 20.3cm)
Length	8	Inch
Width	8	Inch