RENASYS

Basic Information

• Brand Name: RENASYS
• Primary DI: 05000223500191
• Version / Model: 66020797
• Catalog Number: 66020797
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Labeler DUNS: 216344051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-31
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 1883751e-dfbc-4943-965d-16cc5de2d135

Device Description

Renasys-F XL Foam Dressing Kit With Soft Port

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: 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
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34059	Wound dressing kit, medicated	A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05000223500207	GS1	Case	5	In Commercial Distribution
Primary	05000223500191	GS1

Premarket Submissions

Submission Number	Supplement Number
K202783	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			48 x 41 x 1.5cm / 18.9 x 16.1 x 0.6in

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius