Identity
- Trade Name
- CELSITE FDA UDI
- Generic Name
- Vascular port/catheter FDA UDI
- Device Name
- CELSITE ST401L ST SET SIL 10F IV USA FDA UDI
- Model / Reference
- 5430100 FDA UDI
- Description
- CELSITE ST401L ST SET SIL 10F IV USA FDA UDI
Identifiers
- Catalog Number
- 5430100 FDA UDI
- Primary DI / UDI-DI
- 04046963594725 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
- 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 — 10.00 French FDA UDI
Category: Vascular port/catheter
Celsite by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular port/catheter.
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- Vortex — NAVILYST MEDICAL, INC. · Class II
- PowerPort — Bard Access Systems, Inc. · Class II
- Deltec — ICU MEDICAL, INC. · Class II
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 8523a1d1-6acb-474c-8611-9afffda4f40f 37 fields · synced May 30, 2026