Sacca 600 ml circuito chiuso s/rubinetto
EUDAMEDFDA UDIClass I (EU MDR)
by Redax S.p.A.
Identity
- Trade Name
- Sacca 600 ml circuito chiuso s/rubinetto EUDAMEDDrentech Bag - Replacement FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- SACCA DRENAGGIO ALIVIA 2000 ML EUDAMEDCollection bag that can be connected with any gravity or active suction systems for collecting fluids from the patient. FDA UDI
- Model / Reference
- SACCA DRENAGGIO ALIVIA 2000 ML EUDAMED12014 EUDAMEDFDA UDI
- Description
- Collection bag that can be connected with any gravity or active suction systems for collecting fluids from the patient. FDA UDI
Identifiers
- Catalog Number
- 12014 FDA UDI
- Primary DI / UDI-DI
- 08034139291673 EUDAMEDFDA UDI
- Basic UDI-DI
- 803413929BAG1a3F EUDAMED
- FDA Product Code
- GCY FDA UDI
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4680 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Negative-pressure wound therapy system canister
Sacca 600 ml circuito chiuso s/rubinetto by Redax S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, 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
- 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
- Dual filter suction bag 3000 ml — Serres Oy · Class I
- PLASTI-MED — Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803413929BAG1a3F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Redax S.p.A.
- EUDAMED SRN
- IT-MF-000019320
Sources (2)
- EUDAMED 7c35b391-417f-4d99-b66a-25b5bb6d5d9d 61 fields · synced Jul 11, 2026
- FDA UDI a85700c1-e035-45f0-8f17-69eee8b5326f 36 fields · synced May 27, 2026