HIgH-Flo™ Needle Set
26 Gauge Needle Sets - 6 needles - 14 mm
49manufacturers in China registered for this device type
75catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular
Record
| Listed by | Repro-Med Systems, Inc., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| 510(k) | K122404 |
| Record published | 2016-08-19 |
| Record revised | 2026-03-23 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Carton of 10, carton of 20 |
| Sizes | Needle gauge 24 to 26 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RMS12606 | Needle Gauge 26 G | In distribution |
| SUPER12612 | Needle Gauge 26 G | In distribution |
| SUPER22609 | Needle Gauge 26 G | In distribution |
| SUPER32604 | Needle Gauge 26 G | In distribution |
| RMS42606 | Needle Gauge 26 G | In distribution |
| SUPER62606 | Needle Gauge 26 G | In distribution |
| SUPER12606 | Needle Gauge 26 G | In distribution |
| SUPER52614 | Needle Gauge 26 G | In distribution |
| RMS42409 | Needle Gauge 24 G | In distribution |
| RMS32409 | Needle Gauge 24 G | In distribution |
| RMS22406 | Needle Gauge 24 G | In distribution |
| SUPER52606 | Needle Gauge 26 G | In distribution |
| Super12614 | Needle Gauge 26 G | In distribution |
| RMS62614 | Needle Gauge 26 G | In distribution |
| RMS32612 | Needle Gauge 26 G | In distribution |
| RMS52604 | Needle Gauge 26 G | In distribution |
| RMS32412 | Needle Gauge 24 G | In distribution |
| RMS32604 | Needle Gauge 26 G | In distribution |
| SUPER32606 | Needle Gauge 26 G | In distribution |
| SUPER62614 | Needle Gauge 26 G | In distribution |
| RMS22409 | Needle Gauge 24 G | In distribution |
| RMS32606 | Needle Gauge 26 G | In distribution |
| RMS42412 | Needle Gauge 24 G | In distribution |
| SUPER32612 | Needle Gauge 26 G | In distribution |
| SUPER62612 | Needle Gauge 26 G | In distribution |
| RMS32414 | Needle Gauge 24 G | In distribution |
| RMS22614 | Needle Gauge 26 G | In distribution |
| SUPER22606 | Needle Gauge 26 G | In distribution |
| RMS12612 | Needle Gauge 26 G | In distribution |
| SUPER22612 | Needle Gauge 26 G | In distribution |
| RMS22606 | Needle Gauge 26 G | In distribution |
| SUPER52609 | Needle Gauge 26 G | In distribution |
| RMS62606 | Needle Gauge 26 G | In distribution |
| SUPER32614 | Needle Gauge 26 G | In distribution |
| RMS42604 | Needle Gauge 26 G | In distribution |
| RMS42406 | Needle Gauge 24 G | In distribution |
| RMS22612 | Needle Gauge 26 G | In distribution |
| RMS32614 | Needle Gauge 26 G | In distribution |
| SUPER42614 | Needle Gauge 26 G | In distribution |
| SUPER62609 | Needle Gauge 26 G | In distribution |
| RMS12414 | Needle Gauge 24 G | In distribution |
| RMS32609 | Needle Gauge 26 G | In distribution |
| RMS62612 | Needle Gauge 26 G | In distribution |
| RMS22414 | Needle Gauge 24 G | In distribution |
| SUPER42612 | Needle Gauge 26 G | In distribution |
| RMS42609 | Needle Gauge 26 G | In distribution |
| SUPER32609 | Needle Gauge 26 G | In distribution |
| SUPER52604 | Needle Gauge 26 G | In distribution |
| SUPER52612 | Needle Gauge 26 G | In distribution |
| SUPER12604 | Needle Gauge 26 G | In distribution |
| RMS12604 | Needle Gauge 26 G | In distribution |
| RMS62604 | Needle Gauge 26 G | In distribution |
| RMS52606 | Needle Gauge 26 G | In distribution |
| SUPER12609 | Needle Gauge 26 G | In distribution |
| RMS12614 | Needle Gauge 26 G | In distribution |
| RMS42614 | Needle Gauge 26 G | In distribution |
| RMS22609 | Needle Gauge 26 G | In distribution |
| SUPER22614 | Needle Gauge 26 G | In distribution |
| RMS52609 | Needle Gauge 26 G | In distribution |
| RMS62609 | Needle Gauge 26 G | In distribution |
| RMS12609 | Needle Gauge 26 G | In distribution |
| RMS12409 | Needle Gauge 24 G | In distribution |
| RMS12406 | Needle Gauge 24 G | In distribution |
| RMS42612 | Needle Gauge 26 G | In distribution |
| RMS22412 | Needle Gauge 24 G | In distribution |
| SUPER42604 | Needle Gauge 26 G | In distribution |
| SUPER42609 | Needle Gauge 26 G | In distribution |
| RMS52614 | Needle Gauge 26 G | In distribution |
| SUPER22604 | Needle Gauge 26 G | In distribution |
| RMS52612 | Needle Gauge 26 G | In distribution |
| SUPER42606 | Needle Gauge 26 G | In distribution |
| SUPER62604 | Needle Gauge 26 G | In distribution |
| RMS12412 | Needle Gauge 24 G | In distribution |
| RMS22604 | Needle Gauge 26 G | In distribution |
| RMS32406 | Needle Gauge 24 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| Port Access Needle | Bard Access Systems, Inc. | 341 |
| Set, Administration, Intravascular | Mps Medical, Inc. | 291 |
| Alaris, SmartSite | BD Switzerland Sàrl | 266 |
| IV Administration Set | B. Braun Medical Inc. | 242 |
| Medex | ICU Medical, Inc | 237 |
| Extension Set | B. Braun Medical Inc. | 171 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
Showing 12 of 768. All products under Set, Administration, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102512 | 2011-05-20 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Repro-Med Systems, Inc. | 510(k) number | 2019-08-20 | Class II | Under Investigation by firm | Mislabeled needle lengths | 1990 pouches | 2020-05-29 |
| Repro-Med Systems, Inc. | 510(k) number | 2016-03-10 | Class II | Nonconforming Material/Component | On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part numb | 2018-02-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.