Renasys 66020961

GUDID 30040565127232

The RENASYS Procedure Packs are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

SMITH & NEPHEW MEDICAL LIMITED

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• Primary Device ID: 30040565127232
• NIH Device Record Key: 4ee5be83-9b78-4642-822e-df6d78c2363b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renasys
• Version Model Number: 66020961
• Catalog Number: 66020961
• 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: true
• 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	00040565127231 [Primary]
GS1	30040565127232 [Package]; Contains: 00040565127231; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-30
• Device Publish Date: 2019-09-20

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