RENASYS

Basic Information

• Brand Name: RENASYS
• Primary DI: 05000223499792
• Version / Model: 66027660
• Catalog Number: 66027660
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Labeler DUNS: 216344051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-17
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 1f7a000e-1488-4d70-bed3-35d455c1751d

Device Description

RENASYS-WF White Foam NPWT Dressing Large

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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	05000223499785	GS1	Carton	10	In Commercial Distribution
Primary	05000223499792	GS1
Package	05000223501211	GS1	Case	6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K213853	000

Storage Conditions

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