Renasys 66021066

GUDID 00040565127286

Renasys EZPLUS MAX 800ml S Canister without Solidifier (non-sterile)

Smith & Nephew, Inc..

Negative-pressure wound therapy system canister

• Primary Device ID: 00040565127286
• NIH Device Record Key: 133e3aa9-78be-4174-98ad-d2b5699096a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renasys
• Version Model Number: 66021066
• Catalog Number: 66021066
• Company DUNS: 827731451
• Company Name: Smith & Nephew, Inc..
• 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: 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	00040565127286 [Primary]
GS1	30040565127287 [Package]; Package: Case [10 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: 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: 2016-09-23

On-Brand Devices [Renasys]

• 00040565127286: Renasys EZPLUS MAX 800ml S Canister without Solidifier (non-sterile)
• 00040565125565: Renasys EZ Max User Manual
• 30040565127270: Renasys EZPLUS / Max 250ml S-Canister Kit with Solidifier (Non Sterile)
• 30040565127263: Renasys EZPLUS / Max 800ml S-Canister with Soldifier (Non Sterile)
• 30040565125672: RENASYS EZ PLUS/EZ MAX Canister 800ml with solidifier