RENASYS GO SERVICE MANUAL 66021206

GUDID 05000223491475

Negative Pressure Wound Therapy Service Manual

SMITH & NEPHEW MEDICAL LIMITED

Negative-pressure wound therapy system, battery-powered, reusable

• Primary Device ID: 05000223491475
• NIH Device Record Key: 67b305c2-880f-4094-a15f-6c3cea6970bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENASYS GO SERVICE MANUAL
• Version Model Number: 66021206
• Catalog Number: 66021206
• 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: 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	00040565127354 [Primary]
GS1	05000223491475 [Package]; Contains: 00040565127354; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152163

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: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2020-10-02

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

• 05000223503178 - ALLEVYN COMPLETE CARE: 2025-08-07 ALLEVYN COMPLETE CARE M 12.5x12.5 CTN10 silicone gel adhesive composite hydrocellular foam dressing
• 05000223503185 - ALLEVYN COMPLETE CARE: 2025-08-07 ALLEVYN COMPLETE CARE L 15x15 CTN10 silicone gel adhesive composite hydrocellular foam dressing
• 05000223503086 - ALLEVYN COMPLETE CARE: 2025-08-07 ALLEVYN COMPLETE CARE XL 17.5cm x 17.5cm CTN 10
• 05000223503093 - ALLEVYN COMPLETE CARE: 2025-08-07 ALLEVYN COMPLETE CARE S RECT 10x20 CTN10 silicone gel adhesive composite hydrocellular foam dressing
• 05000223503215 - ALLEVYN COMPLETE CARE L Rectangle 10cm x 30cm CTN 10: 2025-08-07 ALLEVYN COMPLETE CARE RECT L 10x30 CTN10 silicone gel adhesive composite hydrocellular foam dressing
• 05000223503222 - ALLEVYN COMPLETE CARE: 2025-08-07 ALLEVYN COMPLETECARE MULTI 17.1x17.8 CTN10 silicone gel adhesive composite hydrocellular foam dressing
• 05000223503123 - ALLEVYN COMPLETE CARE: 2025-08-07 ALLEVYN COMPLETECARE SCRM 17.2x17.4 CTN10 silicone gel adhesive composite hydrocellular foam dressing
• 05000223503130 - ALLEVYN COMPLETE CARE: 2025-08-07 ALLEVYN COMPLETECARE SCRM 21.5x23.0 CTN10 silicone gel adhesive composite hydrocellular foam dressing