Improsafe® Blood Collection Set
The IMPROSAFE blood collection set connects a patient’s vein to an evacuated collection tube to obtain a venous blood specimen. It combines a patient-end needle with flexible tubing and a…
The IMPROSAFE blood collection set connects a patient’s vein to an evacuated collection tube to obtain a venous blood specimen. It combines a patient-end needle with flexible tubing and a non-patient-end needle for the collection tube.
The set provides visible blood flashback and incorporates a safety shield intended to help protect against accidental needle sticks. Its flexible tubing forms the blood pathway between the needle at the vein and the evacuated tube connection.
Supply
The collection set is supplied sterile after ethylene oxide sterilization and is intended for a single use. The listed needle configurations include 21 gauge, 3/4 inch needles.
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 | 2025-03-13 |
| Record revised | 2021-04-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 20, pack of 100, pack of 4, pack of 50, pack of 10, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21G×3/4”×12” | In distribution | |
| 27G x 2/5” x 7” | In distribution | |
| 27G x 2/5” x 12” | In distribution | |
| 25G x 3/4” x 7” | In distribution | |
| 25G x 3/4” x 7” | In distribution | |
| 23G x 3/4” x 7” | In distribution | |
| 27G x 2/5” x 12” | In distribution | |
| 23G x 3/4” 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 | |
| 25G x 3/4” x 12” | In distribution | |
| 21G x 3/4” x 7” | In distribution | |
| 25G x 3/4” x 7” | In distribution | |
| 23G x 3/4” x 7” | In distribution | |
| 21G x 3/4” x 12” | In distribution | |
| 25G x 3/4” x 12” | In distribution | |
| 23G x 3/4” x 7” | In distribution | |
| 27G×2/5”×12” | In distribution | |
| 25G x 3/4” x 7” | In distribution | |
| 21G x 3/4” x 12” | In distribution | |
| 23G x 3/4” x 7” | In distribution | |
| 21G x 3/4” x 7” | In distribution | |
| 23G x 3/4” x 12” | In distribution | |
| 25G x 3/4” x 12” | In distribution | |
| 25G x 3/4” x 12” | In distribution | |
| 21G x 3/4” x 12” | In distribution | |
| 23G x 3/4” x 12” | In distribution | |
| 27G x 2/5” x 12” | In distribution | |
| 27G x 2/5” x 7” | 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.