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Recirc. fll connector with vented cap
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 07103300/S
Identity
- Trade Name
- Recirc. fll connector with vented cap EUDAMED07103300/S FDA UDI
- Generic Name
- Haemodialysis blood tubing set, single-use FDA UDI
- Device Name
- Recirculating FLL connector with protective vented cap and closed cap in blister packaging EUDAMEDRecirculating FLL connector with protective vented cap and closed cap FDA UDI
- Model / Reference
- 07103300/S EUDAMEDFDA UDI
- Description
- Recirculating FLL connector with protective vented cap and closed cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053323800019 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08053323800019 EUDAMED
- 510(k) Number
- K852605 FDA UDI
- FDA Product Code
- FJK FDA UDI
- EMDN Code
- A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMED
- GMDN Term
- Haemodialysis blood tubing set, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Market of Registration
- Italy 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Recirc. fll connector with vented cap by Elcam Medical Italy Spa — 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-08053323800019 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Elcam Medical Italy SpA
- EUDAMED SRN
- IT-MF-000012119
Sources (2)
- EUDAMED 833f2fba-3873-4728-9e23-9aff620d4a67 61 fields · synced Jul 16, 2026
- FDA UDI 2f519e38-d017-4e43-9f4d-15ffa038358f 35 fields · synced May 29, 2026