RENASYS TOUCH DEVICE & POWER SUP 66801281

GUDID 05000223494476

A powered suction pump with accessory Wound Dressing Kits designed for Negative Pressure Wound Therapy (NPWT).

SMITH & NEPHEW MEDICAL LIMITED

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• Primary Device ID: 05000223494476
• NIH Device Record Key: 5b70ec4d-77bd-4b6e-9725-d56f0b87ed24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENASYS TOUCH DEVICE & POWER SUP
• Version Model Number: 66801281
• Catalog Number: 66801281
• 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	05000223494476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181204

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: 2019-10-23
• Device Publish Date: 2019-10-15

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