Identity
- Trade Name
- ExtriCARE FDA UDI
- Generic Name
- Negative-pressure wound therapy system canister FDA UDI
- Device Name
- Extricare 3600 400cc Canister FDA UDI
- Model / Reference
- MI393-0001 FDA UDI
- Description
- Extricare 3600 400cc Canister FDA UDI
Identifiers
- Catalog Number
- EC3600-400C-E FDA UDI
- Primary DI / UDI-DI
- 04897089070057 FDA UDI
- 510(k) Number
- K140634 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Negative-pressure wound therapy system canister
ExtriCARE by Alleva 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
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
- Alleva Medical, Ltd.
Sources (1)
- FDA UDI 849ef7a1-6dd0-432a-b773-340fc158d304 35 fields · synced May 30, 2026