Identity
- Trade Name
- Renasys FDA UDI
- Generic Name
- Negative-pressure wound therapy system canister FDA UDI
- Device Name
- Renasys EZPLUS / Max 250ml S-Canister Kit with Solidifier (Non Sterile) FDA UDI
- Model / Reference
- 66020913 FDA UDI
- Description
- Renasys EZPLUS / Max 250ml S-Canister Kit with Solidifier (Non Sterile) FDA UDI
Identifiers
- Catalog Number
- 66020913 FDA UDI
- Primary DI / UDI-DI
- 00040565127279 FDA UDI
- 510(k) Number
- K142979 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system canister 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
MR Unsafe FDA UDI
Category: Negative-pressure wound therapy system canister
Renasys 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 canister.
- Webura — WEIHAI WEIBO MEDICAL TECHNOLOGY CO.,LTD · Class I
- Dual filter suction bag 2000 ml — Serres Oy · Class I
- PLASTI-MED — Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. · Class I
- Sacca 600 ml circuito chiuso s/rubinetto — Redax S.p.A. · Class I
- Webura — WEIHAI WEIBO MEDICAL TECHNOLOGY CO.,LTD · Class I
- Suction liner 2000ML (without shut-off filter, pre-loaded SAP) — Yung Kang Medical Device Technology Co., Ltd. · Class I
- YDC Suction liner with shutoff filter with solidifying agent 2000ml — Shijiazhuang Yuanding Medical Device Co.,LTD · Class I
- Sacca 600 ml circuito chiuso c/filtro — Redax S.p.A. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI 043c4a08-618c-4bcc-89f6-b2aa2df722d6 35 fields · synced May 30, 2026