Identity
- Trade Name
- RENASYS GO FDA UDI
- Generic Name
- Negative-pressure wound therapy system, battery-powered, reusable FDA UDI
- Device Name
- Home Healthcare User Manual US Only FDA UDI
- Model / Reference
- 66021815 FDA UDI
- Description
- Home Healthcare User Manual US Only FDA UDI
Identifiers
- Catalog Number
- 66021815 FDA UDI
- Primary DI / UDI-DI
- 00040565127392 FDA UDI
- 510(k) Number
- K152163 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system, battery-powered, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Negative-pressure wound therapy system, battery-powered, reusable
Renasys Go by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system, battery-powered, reusable.
- ACTIV.A.C.™ — KCI USA, INC. · Class II
- ACTIV.A.C. ™ — KCI USA, INC. · Class II
- RENASYS GO — Smith & Nephew Medical, Ltd. · Class II
- RENASYS GO — Smith & Nephew Medical, Ltd. · Class II
- RENASYS TOUCH — Smith & Nephew Medical, Ltd. · Class II
- RENASYS GO — Smith & Nephew Medical, Ltd. · Class II
- RENASYS GO — Smith & Nephew Medical, Ltd. · Class II
- RENASYS GO v2 HOME — Smith & Nephew Medical, Ltd. · Class II
Cleared under the same submission
K152163 also covers:
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO — Smith & Nephew Medical, Ltd.
- RENASYS GO SERVICE MANUAL — Smith & Nephew Medical, Ltd.
- RENASYS GO v2 HOME — Smith & Nephew Medical, Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI 0c81528e-d57f-403d-bb3e-e709e30b272f 35 fields · synced Jun 8, 2026