Renasys 66801309

GUDID 00040565126470

Renasys EZ Max Hospital

SMITH & NEPHEW MEDICAL LIMITED

Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, line-powered Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable Negative-pressure wound therapy system, electric, reusable

• Primary Device ID: 00040565126470
• NIH Device Record Key: df653ff6-02cc-4625-9b35-ddfe679b1315
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renasys
• Version Model Number: 66801309
• Catalog Number: 66801309
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00040565126470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142979

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-08
• Device Publish Date: 2016-09-20

On-Brand Devices [Renasys]

• 00040565123943: Power Cord North America
• 30040565127232: The RENASYS Procedure Packs are intended to be used in conjunction with Smith & Nephew NPWT syst
• 00040565127309: Renasys Canister Ring Holder US
• 00040565126883: RENASYS GO/TOUCH Class II Power Cord
• 00040565126470: Renasys EZ Max Hospital
• 05000223491499: Renasys EZ Max Quick Reference Guide US
• 30040565127249: Renasys Soft Port Stand Alone
• 30040565125627: Renasys Transparent Film Kit (Just Drapes)
• 05000223499785: RENASYS-WF White Foam NPWT Dressing Large
• 05000223499761: RENASYS-WF White Foam NPWT Dressing Small
• 30040565125689: Renasys EZ Plus Canister 250ml
• 05000223500207: Renasys-F XL Foam Dressing Kit With Soft Port
• 05000223500184: Renasys XL Transparent Film Dressing