Q2 IV Administration Set
Q2 IV Administration Sets deliver intravenous fluids through needleless components and a manifold for simultaneous therapies. They can carry fluid from gravity, syringe or infusion-pump…
Q2 IV Administration Sets deliver intravenous fluids through needleless components and a manifold for simultaneous therapies. They can carry fluid from gravity, syringe or infusion-pump sources to the patient’s vascular system.
Set configurations can include a multiport manifold, back-check valves, pre-attached needleless sites, a drip chamber and roller clamps. The exact component combination varies by model.
Fluid-Path Materials and Supply
The covered tubing and drip-chamber formulations are made without DEHP plasticizer. The sets are sterile, nonpyrogenic and single-use, with ethylene-oxide sterilization. Luer activation provides access through the needleless system, while the manifold organizes one or several infusates.
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 | Quest Medical, Inc., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K162304 |
| Record published | 2020-06-25 |
| Record revised | 2026-07-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 50 |
| Distribution end date | 2024-11-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ASV102Y | Withdrawn | |
| ASV103Y | Withdrawn | |
| ASV10125 | Withdrawn | |
| ASV60125 | Withdrawn | |
| ASV10115 | Withdrawn | |
| ASV101Y | Withdrawn | |
| ASV10130 | Withdrawn |
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 |
|---|---|
| K241058 | 2024-12-18 |
| K213846 | 2022-06-05 |
| K213588 | 2022-06-02 |
| K202672 | 2021-01-21 |
| K162804 | 2017-03-08 |
| K162304 | 2016-12-06 |
| K151079 | 2015-09-30 |
| K040385 | 2004-04-07 |
| K002689 | 2001-03-06 |
| K860157 | 1986-04-09 |
| K841361 | 1984-05-21 |
| K811685 | 1981-06-30 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-07-14 | Class II | Material/Component Contamination | For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may | 17,700 units |
| 2022-12-23 | Class II | Process control | Delivery Sets may have tubing that could become detached that could result in patient infection. | 13,900 |
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.