Renasys 66020799

GUDID 30040565127249

Renasys Soft Port Stand Alone

SMITH & NEPHEW MEDICAL LIMITED

Wound dressing kit, medicated, sterile

• Primary Device ID: 30040565127249
• NIH Device Record Key: ce5978d9-5645-4cdc-b28a-bba5339b3729
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renasys
• Version Model Number: 66020799
• Catalog Number: 66020799
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00040565127248 [Primary]
GS1	30040565127249 [Package]; Contains: 00040565127248; Package: Case [5 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-06-22
• Device Publish Date: 2016-09-23

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