Identity
- Trade Name
- 175IBLSSC FDA UDI
- Generic Name
- Catheter injection port FDA UDI
- Device Name
- Catheter Injection port FDA UDI
- Model / Reference
- 175IBLSSC FDA UDI
- Description
- Catheter Injection port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053323800026 FDA UDI
- 510(k) Number
- K855039 FDA UDI
- FDA Product Code
- GCE FDA UDI
- GMDN Term
- Catheter injection port FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Catheter injection port
175iblssc by Elcam Medical Italy Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K855039 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Elcam Medical Italy Spa
Sources (1)
- FDA UDI 137d93aa-4323-424e-9eb6-22cc89522633 34 fields · synced May 31, 2026