Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Breathing circuit condensate trap, reusable FDA UDI
- Device Name
- D-fend+ Water Trap, green EUDAMED
- Model / Reference
- 881319-HEL EUDAMEDD-fend Water Trap, 881319-HEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682102810 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682102810 EUDAMED
- 510(k) Number
- K051092 FDA UDI
- FDA Product Code
- NHO FDA UDICAP FDA UDICCL FDA UDINHP FDA UDICBQ FDA UDICBS FDA UDINHQ FDA UDIBZL FDA UDICBR FDA UDIBZK FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Breathing circuit condensate trap, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1500 FDA UDI868.2600 FDA UDI868.1720 FDA UDI868.1620 FDA UDI868.1730 FDA UDI868.1700 FDA UDI868.1850 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
D-fend+ Water Trap, green by GE Healthcare Finland Oy — Class IIa — 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-00840682102810 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED e868302e-a62f-42c3-9872-313cc0a8b843 61 fields · synced Jun 17, 2026
- FDA UDI d2f96782-bd38-41e8-90da-1d2414db2ab2 33 fields · synced May 30, 2026