Renasys Touch 66801791

GUDID 05000223490782

RENASYS TOUCH CONNECT Pump provides negative pressure therapy to a wound at a range of pressure settings via a tube set connected to a wound dressing. Pressure setting deliver setup is selectable via LCD screen. The suction pump creates negative pressure and removes exudate from the wound site to a disposable canister. The device can operate by either an external mains power supply or internal battery. The RENASYS TOUCH CONNECT pump has the facility to connect wirelessly to a cloud based system. Several accessories are available for use with the Pump including Canisters, Power supply either Class I or II, Carry Bag, Carry Strap and IV Pole/Bed Clamp. The Pump is suitable for use in both hospital and homecare settings. The Pump is compatible with existing Smith & Nephew Negative Pressure wound dressing kits on the market.

SMITH & NEPHEW MEDICAL LIMITED

Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable

• Primary Device ID: 05000223490782
• NIH Device Record Key: 327cf6ee-13d9-4342-8ed8-f976ba56021e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renasys Touch
• Version Model Number: 66801791
• Catalog Number: 66801791
• 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: true
• 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	05000223490782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181822

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-02
• Device Publish Date: 2019-06-24

On-Brand Devices [Renasys Touch]

• 05000223491567: RENASYS TOUCH CLINICIAN MANUAL US
• 00040565126494: RENASYS TOUCH IV Pole/Bed Clamp
• 05000223490782: RENASYS TOUCH CONNECT Pump provides negative pressure therapy to a wound at a range of pressure
• 00040565126586: RENASYS TOUCH DEVICE
• 00040565126630: RENASYS TOUCH Class II Power Supply
• 30040565126549: RENASYS TOUCH 300ml Canister without Solidifier
• 30040565126532: RENASYS TOUCH 800ml Canister with Solidifier
• 30040565126525: RENASYS TOUCH 300ml Canister with Solidifier
• 30040565126617: RENASYS TOUCH Odor Filter
• 30040565126600: RENASYS TOUCH O-Ring
• 30040565126563: RENASYS TOUCH CARRY BAG
• 30040565126556: RENASYS TOUCH CARRY STRAP