Identity
- Trade Name
- UNBRANDED FDA UDI
- Generic Name
- Extracorporeal circuit waste bag FDA UDI
- Device Name
- Metallocene Uro Drain Bag EUDAMEDUrologic Drain Bag FDA UDI
- Model / Reference
- 056397-910 EUDAMEDFDA UDI
- Description
- Urologic Drain Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848340009488 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00848340009488 EUDAMED
- 510(k) Number
- K012168 FDA UDI
- FDA Product Code
- KKX FDA UDI
- EMDN Code
- F9099 DIALYSIS DEVICES - OTHER EUDAMED
- GMDN Term
- Extracorporeal circuit waste bag FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Ethylene Oxide FDA UDI
Metallocene Uro Drain Bag by Advance Medical Designs, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00848340009488 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Advance Medical Designs, Inc.
- EUDAMED SRN
- US-MF-000009790
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 11c44456-32eb-4c0a-bea7-61645c710fa0 61 fields · synced Oct 7, 2026
- FDA UDI df132d21-fffd-4bbd-a3f7-a2bb93c5f4b5 34 fields · synced May 25, 2026