RENASYS® 66020971

GUDID 05000223493592

Renasys Y-Connector US Non-sterile

SMITH & NEPHEW MEDICAL LIMITED

Negative-pressure wound therapy tubing set

• Primary Device ID: 05000223493592
• NIH Device Record Key: e9c0fc49-9e47-4ae6-b80d-a7d2c4713272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENASYS®
• Version Model Number: 66020971
• Catalog Number: 66020971
• 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: true
• 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	05000223493592 [Primary]
GS1	05000223493608 [Package]; Package: case [10 Units]; In Commercial Distribution

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: 2019-02-25
• Device Publish Date: 2019-01-24

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