URGOK2

Basic Information

• Brand Name: URGOK2
• Primary DI: 00190769532437
• Version / Model: 553243
• Catalog Number: 553243
• Company Name: URGO MEDICAL NORTH AMERICA, LLC
• Labeler DUNS: 052758618
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-26
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: f626ef75-8624-47a4-ad6d-74a2a873c36b

Device Description

UrgoK2 is a two Layer Compression System -KTECH; a short - stretch bandage, providing compression, protection and absorbency and KPRESS; a cohesive long-stretch bandage providing the compression necessary to achieve therapeutic pressure and secures the bandages in place. UrgoK2 is for the treatment of venous leg ulcers, venous edema and lymphedema requiring full compression. Not made with natural rubber latex.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
FQM	Bandage, Elastic	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58983	Compression bandaging kit	A collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10190769532434	GS1	case	21	In Commercial Distribution
Primary	00190769532437	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Width of bandages: 4 inches (10 cm)
Device Size Text, specify			For Ankle circumference: 7 1/8 - 9 3/4 inches (18 - 25 cm)
Device Size Text, specify			KPRESS = 7.8 yards stretched
Device Size Text, specify			KTECH = 6.6 yards

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store away from light and heat.