RENASYS TOUCH 66801280

GUDID 00040565126586

RENASYS TOUCH DEVICE

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

• Primary Device ID: 00040565126586
• NIH Device Record Key: b575566f-fd1a-4df1-9f39-b276c37438ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENASYS TOUCH
• Version Model Number: 66801280
• Catalog Number: 66801280
• 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	00040565126586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153209

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: 2016-10-28

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