Identity
- Trade Name
- Renasys FDA UDI
- Generic Name
- Wound dressing kit, medicated FDA UDI
- Device Name
- The RENASYS Procedure Packs are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts. FDA UDI
- Model / Reference
- 66020961 FDA UDI
- Description
- The RENASYS Procedure Packs are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts. FDA UDI
Identifiers
- Catalog Number
- 66020961 FDA UDI
- Primary DI / UDI-DI
- 00040565127231 FDA UDI
- 510(k) Number
- K142979 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Wound dressing kit, medicated 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Wound dressing kit, medicated
Renasys by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142979 also covers:
- ANTIMICROBIAL GAUZE — Smith & Nephew Medical, Ltd.
- FOAM WOUND DRESSING — Smith & Nephew Medical, Ltd.
- Foam 10x12.5cm Pack 1 — Smith & Nephew Medical, Ltd.
- NPWT Antimicrobial Large Gauze Roll — Smith & Nephew Medical, Ltd.
- RENASYS F LARGE W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENASYS F MEDIUM W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENASYS F SMALL W/SOFT PORT — Smith & Nephew Medical, Ltd.
- Renasys — Smith & Nephew Medical, Ltd.
- Renasys — Smith & Nephew Medical, Ltd.
- Renasys — Smith & Nephew Medical, Ltd.
- Renasys — 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 |
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Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI 4ee5be83-9b78-4642-822e-df6d78c2363b 35 fields · synced Jun 8, 2026