FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Precision Flow Tubing EUDAMEDRMS Precision Flow Rate TubingTM FDA UDI
- Generic Name
- Mechanical infusion pump administration set FDA UDI
- Device Name
- Flow Control Infusion Tubing FDA UDI
- Model / Reference
- F2 EUDAMEDFDA UDIPrecision Flow Tubing EUDAMED
- Description
- Flow Control Infusion Tubing FDA UDI
Identifiers
- Catalog Number
- F2 FDA UDI
- Primary DI / UDI-DI
- 00659443000049 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00659443000049 EUDAMED
- FDA Product Code
- FRN FDA 510(k)FDA UDI
- EMDN Code
- A0399 TUBULAR DEVICES - OTHER EUDAMED
- GMDN Term
- Mechanical infusion pump administration set FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.006 Inch FDA UDI
The FreedomEdge Infusion System is a Class II infusion pump designed for controlled delivery of fluids, including subcutaneous infusions. It incorporates a High-Flo Subcutaneous (SubQ) Needle Set for efficient fluid administration and Precision Flow Rate Tubing to ensure accurate dosing. This system is intended for use in general hospital settings, providing reliable infusion therapy for patients requiring continuous or intermittent fluid administration.
The device is supplied as a reusable infusion pump system with single-use components, including the High-Flo SubQ Needle Set and Precision Flow Rate Tubing. It is intended for use in environments where MRI safety is not a concern, as no specific MRI compatibility is stated. The system requires proper training for setup, calibration, and operation, adhering to standard infusion protocols. Authorized for use under FDA 510(k) clearance and MDD compliance, it is regulated under the classification of infusion pumps (OpenFDA: device_class=2).
Manufacturer's product page: HigH-Flo™ SubQ Needle Sets
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252015 | Class II | Active |
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Manufacturer
- Manufacturer
- KORU Medical Systems, Inc
- FDA Applicant
- Koru Medical Systems, Inc.
Sources (3)
- FDA 510(k) K252015 24 fields · synced Sep 18, 2026
- FDA UDI 4df30c47-445f-4d2f-9533-1ef50a1e3ff1 38 fields · synced May 29, 2026
- EUDAMED f93a9290-0c81-4a2b-a5c6-92c5b58a992c 61 fields · synced Jul 9, 2026