RENASYS® TOUCH 66020801

GUDID 05000223496296

RENASYS TOUCH Clinician Manual US

SMITH & NEPHEW MEDICAL LIMITED

Negative-pressure wound therapy system canister

• Primary Device ID: 05000223496296
• NIH Device Record Key: e0842434-f05d-4d08-a4c0-5697431b4cf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENASYS® TOUCH
• Version Model Number: 66020801
• Catalog Number: 66020801
• 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: true
• Lot Batch: false
• 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	05000223496173 [Package]; Package: Case [100 Units]; In Commercial Distribution
GS1	05000223496296 [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: 2019-04-15
• Device Publish Date: 2019-04-05

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

• 05000223499389 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, large
• 05000223499396 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, medium
• 05000223499402 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, small
• 05000223504267 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, large
• 05000223504274 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, medium
• 05000223504281 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, small
• 05000223501686 - ALLEVYN™ Ag+: 2025-08-20 ALLEVYN AG+ 3.9IN X 3.9IN
• 05000223501693 - ALLEVYN™ Ag+: 2025-08-20 ALLEVYN AG+ 4.9IN X 4.9IN