Identity
- Trade Name
- RENASYS TOUCH FDA UDI
- Generic Name
- Negative-pressure wound therapy system, electric, reusable FDA UDI
- Device Name
- RENASYS TOUCH 300ml Canister without Solidifier FDA UDI
- Model / Reference
- 66801275 FDA UDI
- Description
- RENASYS TOUCH 300ml Canister without Solidifier FDA UDI
Identifiers
- Catalog Number
- 66801275 FDA UDI
- Primary DI / UDI-DI
- 00040565126548 FDA UDI
- 510(k) Number
- K153209 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system, electric, 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Negative-pressure wound therapy system, electric, reusable
Renasys Touch by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system, electric, reusable.
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- Vcare Alpha — IVT Medical, Ltd. · Class I
- Vcare Alpha — IVT Medical, Ltd. · Class I
Cleared under the same submission
K153209 also covers:
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH — Smith & Nephew Medical, Ltd.
- RENASYS TOUCH Class I Power Supply — Smith & Nephew Medical, Ltd.
- RENASYS™ — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI a007e958-5603-457d-9d0d-3dc0a47484d7 35 fields · synced Jun 8, 2026