Sacca 600 ml per circuito chiuso
EUDAMEDFDA UDIClass I (EU MDR)
by Redax S.p.A.
Identity
- Trade Name
- Sacca 600 ml per circuito chiuso 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 EUDAMED12004 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
- 12004 FDA UDI
- Primary DI / UDI-DI
- 08034139291598 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 per circuito chiuso by Redax S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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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 |
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Manufacturer
- Manufacturer
- Redax S.p.A.
- EUDAMED SRN
- IT-MF-000019320
Sources (2)
- EUDAMED 1300bd72-dbeb-4d5c-b9e8-382214b8d29e 61 fields · synced Jul 11, 2026
- FDA UDI e509636e-9ec4-4fe4-8523-97fe691ec130 36 fields · synced May 30, 2026