Identity
- Trade Name
- CELSITE FDA UDI
- Generic Name
- Vascular port/catheter FDA UDI
- Device Name
- CELSITE ST505H SM SET PUR8.5F IV USA FDA UDI
- Model / Reference
- 5437028 FDA UDI
- Description
- CELSITE ST505H SM SET PUR8.5F IV USA FDA UDI
Identifiers
- Catalog Number
- 5437028 FDA UDI
- Primary DI / UDI-DI
- 04046963595135 FDA UDI
- FDA Product Code
- LJT FDA UDI
- GMDN Term
- Vascular port/catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5965 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Catheter Gauge — 8.50 French FDA UDI
Celsite by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- B Braun Interventional Systems, Inc
Sources (1)
- FDA UDI 78507a47-5954-4b34-a1ff-3da6f16629c0 38 fields · synced Jun 8, 2026