Improvacuter® Blood Collection Set
Improvacuter Blood Collection Set connects a patient-end needle to an evacuated blood collection tube. Flexible tubing carries blood between the venous access needle and the tube-end…
Improvacuter Blood Collection Set connects a patient-end needle to an evacuated blood collection tube. Flexible tubing carries blood between the venous access needle and the tube-end needle, forming the collection pathway.
The set range includes versions with a pre-attached holder and versions without one. The holder supports the collection tube at the tube-end needle, while the tubing separates that handling point from the venous access site.
Flashback and Needle Choices
The blood collection set configurations provide visible flashback for observing blood return. Needle options include 21, 23, 25 and 27 gauge, with different needle lengths available for the selected set.
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Guangzhou Improve Medical Instruments Co., Ltd., China |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K153388 |
| Record published | 2016-12-23 |
| Record revised | 2021-04-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 100, pack of 20, pack of 4, pack of 50, pack of 10, 20(100*20) of 2000 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 27G x 2/5” x 7” | In distribution | |
| 25G x 3/4” x 12” | In distribution | |
| 27G x 2/5” x 12” | In distribution | |
| 25G x 3/4” x 7” | In distribution | |
| 27G x 2/5” x 12” | In distribution | |
| 27G x 2/5” x 7” | In distribution | |
| 23G x 3/4” x 12” | In distribution | |
| 21G x 3/4” x 7” | In distribution | |
| 21Gx3/4”x12” | In distribution | |
| 23G x 3/4” x 7” | In distribution | |
| 21G x 3/4” x 7” | In distribution | |
| 23G x 3/4” x 7” | In distribution | |
| 23G x 3/4” x 12” | In distribution | |
| 21G x 3/4” x 7” | In distribution | |
| 23G x 3/4” x 12” | In distribution | |
| 21G x 3/4” x 12” | In distribution | |
| 25G x 3/4” x 7” | In distribution | |
| 27G x 2/5” x 12” | In distribution | |
| 27G x 2/5” x 7” | In distribution | |
| 23G×3/4”×12” | In distribution | |
| 25G x 3/4” x 12” | In distribution | |
| 23G x 3/4” x 7” | In distribution | |
| 25G×3/4”×12” | In distribution | |
| 25G x 3/4” x 7” | In distribution | |
| 21G x 3/4” x 12” | In distribution | |
| 21G x 3/4” x 12” | In distribution | |
| 25G x 3/4” x 12” | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health | 124 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153388 | 2016-06-07 |
Recalls
3 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 |
|---|---|---|---|---|
| 2017-09-22 | Class II | Nonconforming Material/Component | Complain due to the hub needle came out when the nurse draw the blood and removed the tube. | 550,000 |
| 2017-09-22 | Class II | Under Investigation by firm | Leaks complaints. | 200,000 |
| 2016-10-19 | Class II | Nonconforming Material/Component | Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip. | 700,000 |
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.