HIgH-Flo™ Needle Set
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- High-Flo Subcutaneous Safety Needle Sets EUDAMEDHIgH-Flo™ Needle Set FDA UDI
- Generic Name
- Subcutaneous infusion/injection port needle FDA UDI
- Device Name
- 26 Gauge Needle Sets - 6 needles - 14 mm FDA UDI
- Model / Reference
- RMS62614 EUDAMEDFDA UDIHigh-Flo Subcutaneous Safety Needle Sets EUDAMED
- Description
- 26 Gauge Needle Sets - 6 needles - 14 mm FDA UDI
Identifiers
- Catalog Number
- RMS62614 FDA UDI
- Primary DI / UDI-DI
- 00659443000520 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00659443000520 EUDAMED
- 510(k) Number
- K122404 FDA UDI
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- A010199 NEEDLES FOR INFUSION AND COLLECTION - OTHER EUDAMED
- GMDN Term
- Subcutaneous infusion/injection port needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- 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
- Needle Gauge — 26 Gauge FDA UDI
Category: Subcutaneous infusion/injection port needle
HIgH-Flo™ Needle Set by Repro Med Systems, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Subcutaneous infusion/injection port needle.
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Cleared under the same submission
K122404 also covers:
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Repro Med Systems, Inc.
Sources (2)
- FDA UDI 5e92def2-5399-4f3b-815f-3d2432b56550 37 fields · synced Jul 9, 2026
- EUDAMED 6917299d-904c-45d8-9898-9040b6e2a3f2 61 fields · synced Jul 9, 2026