Identity
- Trade Name
- DeClogger EUDAMEDBlue DeClogger® FDA UDI
- Generic Name
- Enteral feeding tube clearing kit FDA UDI
- Device Name
- DeClogger EUDAMEDBlue DeClogger® FDA UDI
- Model / Reference
- 911 EUDAMEDFDA UDI
- Description
- Blue DeClogger® FDA UDI
Identifiers
- Catalog Number
- 911 FDA UDI
- Primary DI / UDI-DI
- 00859911004221 EUDAMEDFDA UDI
- Basic UDI-DI
- 859911004DeCloggerYM EUDAMED
- Unit of Use DI
- 10859911004228 EUDAMED
- 510(k) Number
- K905164 FDA UDI
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Enteral feeding tube clearing kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Market of Registration
- Belgium 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Category: Device sterilization/disinfection container, reusable
DeClogger by Bionix, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 859911004DeCloggerYM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bionix LLC
- EUDAMED SRN
- US-MF-000020408
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED bf09362e-5bd1-43ea-98c2-d8c8b7eb52e3 61 fields · synced Jul 29, 2026
- FDA UDI 2abfcc45-03e3-4516-97f6-d023787d723e 36 fields · synced May 30, 2026