RENASYS TOUCH 66801286

GUDID 00040565126630

RENASYS TOUCH Class II Power Supply

SMITH & NEPHEW MEDICAL LIMITED

Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable Basic power supply, reusable

• Primary Device ID: 00040565126630
• NIH Device Record Key: 637e934b-f9f0-409f-a8bf-7f6419acae64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENASYS TOUCH
• Version Model Number: 66801286
• Catalog Number: 66801286
• 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: false
• 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	00040565126630 [Primary]
GS1	30040565126631 [Package]; Package: Case [10 Units]; In Commercial Distribution

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: 2021-07-22
• Device Publish Date: 2016-11-02

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