Identity
- Trade Name
- BIO-PRF FDA UDI
- Generic Name
- Basic intravenous administration set, invasive FDA UDI
- Device Name
- BIO-PRF IV Connectors - Large IV Tube Holders FDA UDI
- Model / Reference
- BIO-PRF-IV-Connect FDA UDI
- Description
- BIO-PRF IV Connectors - Large IV Tube Holders FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841336112124 FDA UDI
- 510(k) Number
- K011786 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Basic intravenous administration set, invasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic intravenous administration set, invasive
Bio-Prf by Salvin Dental Specialties, Llc — 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
- SURFLO™ — Terumo Europe NV · Class II
- SURSHIELD — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- SURFLO™ — Terumo Europe NV · Class II
- VACUETTE — Greiner Bio-One GmbH · Class II
- ULTRAFLO-R — Innovative Medical Technologies, Inc. · Class II
Cleared under the same submission
K011786 also covers:
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
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
- Salvin Dental Specialties, Llc
Sources (1)
- FDA UDI c96832b8-4740-40cb-8481-f6f90f4db8e5 35 fields · synced May 30, 2026