RENASYS F SMALL W/SOFT PORT 66020794

GUDID 30040565127164

RENASYS-F Foam Dressing Kit with Soft Port Small

SMITH & NEPHEW MEDICAL LIMITED

Wound dressing kit, medicated, sterile

• Primary Device ID: 30040565127164
• NIH Device Record Key: 4ac67877-9b1d-430b-86d2-cb49639cb422
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENASYS F SMALL W/SOFT PORT
• Version Model Number: 66020794
• Catalog Number: 66020794
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00040565127163 [Primary]
GS1	30040565127164 [Package]; Contains: 00040565127163; Package: Case [5 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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-04
• Device Publish Date: 2020-04-24

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