Identity
- Trade Name
- SURFLO™ FDA UDI
- Generic Name
- Basic intravenous administration set, invasive FDA UDI
- Device Name
- SURFLO™ WINGED INFUSION SET WITH NEEDLE PROTECTION FDA UDI
- Model / Reference
- SV-S23WL35 FDA UDI
- Description
- SURFLO™ WINGED INFUSION SET WITH NEEDLE PROTECTION FDA UDI
Identifiers
- Catalog Number
- SV-S23WL35 FDA UDI
- Primary DI / UDI-DI
- 05413206055906 FDA UDI
- 510(k) Number
- K133867 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Basic intravenous administration set, invasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 23 Gauge FDA UDI
Category: Basic intravenous administration set, invasive
Surflo™ by Terumo Europe NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic intravenous administration set, invasive.
- Vacuette — Greiner Bio-One GmbH · Class II
- SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- SURSHIELD — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- VACUETTE — Greiner Bio-One GmbH · Class II
- ULTRAFLO-R — Innovative Medical Technologies, Inc. · Class II
- SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
Cleared under the same submission
K133867 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 II | Pending data |
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Manufacturer
- Manufacturer
- Terumo Europe NV
Sources (1)
- FDA UDI 304e78f7-70fa-4ee2-ba8b-1995bb241fab 38 fields · synced Jun 1, 2026