RENASYS EDGE

Basic Information

• Brand Name: RENASYS EDGE
• Primary DI: 05000223501129
• Version / Model: 66803136
• Catalog Number: 66803136
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Labeler DUNS: 216344051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-26
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 7e5a9cd9-1d1d-4e1d-8c26-9db258245d9e

Device Description

RENASYS EDGE Carry Bag

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
20395	Negative-pressure wound therapy system, electric, reusable	An assembly of devices designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps, and grafts with suction. It typically consists of a dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, an evacuation tube, a collection canister, and an electrically-powered vacuum pump. The pump applies continuous or intermittent negative pressure to the wound via the tube to the dressing which decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05000223501136	GS1	Case	50	In Commercial Distribution
Primary	05000223501129	GS1

Premarket Submissions

Submission Number	Supplement Number
K223041	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			172x135 x134W x H x Dmm (approximate dimensions with strap at longest)

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius