Improsafe® Multi Sample Needle
The IMPROSAFE Multi-Sample Needle is used with an evacuated blood collection tube to collect venous blood. It includes patient-end and non-patient-end needles and a safety shield. The…
The IMPROSAFE Multi-Sample Needle is used with an evacuated blood collection tube to collect venous blood. It includes patient-end and non-patient-end needles and a safety shield.
The shield is intended to help protect against accidental needle sticks. This needle is a separate configuration from the blood collection sets, which have flexible tubing.
Collection Configuration
The multi-sample needle configuration includes a pre-attached holder and has no flexible tubing. It is listed separately from the IMPROSAFE Flashback version.
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 6) |
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 4, pack of 50, pack of 10, pack of 25, pack of 8, 8(25*8) of 200 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22G × 1 1/2″ | In distribution | |
| 22G x 1 1/2” | In distribution | |
| 21G×1 1/2” | In distribution | |
| 22G × 1″ | In distribution | |
| 22G × 1″ | In distribution | |
| 22G×1 1/2” | In distribution | |
| 21G × 1″ | In distribution | |
| 21G×1” | In distribution | |
| 21G × 1 1/2″ | In distribution | |
| 22G × 1 1/2″ | In distribution | |
| 21G × 1 1/2″ | In distribution | |
| 21G x 1 1/2” | In distribution | |
| 21G x 1” | In distribution | |
| 22G×1” | In distribution | |
| 21G × 1″ | In distribution | |
| 22G x 1” | 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.