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

• 05000223402464 - IV3000 6X8CM-CARTON OF 100: 2023-09-07 Moisture responsive IV catheter dressing
• 05000223049249 - IV3000 6X8.5CM-CARTON OF 10: 2023-09-07 Moisture responsive IV catheter dressing
• 05000223049256 - IV3000: 2023-09-07 Moisture responsive catheter dressing. 10cm x 14cm Ctn of 10
• 05000223463113 - OPSITE POST-OP VISIBLE 20X10CM CTN 20: 2023-09-07 Waterproof, bacteria proof dressing with absorbent see through pad
• 00040565122564 - IODOSORB: 2023-09-07 Cadexomer iodine gel. 10g. Ctn of 1 Tube
• 05000223500184 - RENASYS: 2023-09-07 Renasys XL Transparent Film Dressing
• 05000223500207 - RENASYS: 2023-09-07 Renasys-F XL Foam Dressing Kit With Soft Port
• 30040565118254 - IV3000: 2023-09-07 4” x 5” Non-Sterile Bulk