Vacuette
VACUETTE® EVOPROTECT SAFETY Blood Collection Set + Luer Adapter 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex or DEHP
71manufacturers in China registered for this device type
68catalogue numbers in this listing
1recall
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 | Greiner BIO-ONE Gmbh, Austria |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K973620 |
| Record published | 2016-09-23 |
| Record revised | 2023-09-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 36 °C |
| Packaging | Pack of 20, pack of 12, pack of 3, pack of 30, pack of 18, pack of 50 |
| Distribution end date | 2024-05-13 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 450077 | 100 | In distribution | |
| 450235V1 | In distribution | ||
| 450090 | In distribution | ||
| 450083 | In distribution | ||
| 450082V1 | In distribution | ||
| 450126 | In distribution | ||
| 450096V1 | In distribution | ||
| 450095V1 | In distribution | ||
| 450120 | In distribution | ||
| 450096 | In distribution | ||
| 450121 | In distribution | ||
| 450210 | In distribution | ||
| 450099V1 | In distribution | ||
| 450132 | In distribution | ||
| 450082 | In distribution | ||
| 450072 | 100 | In distribution | |
| 450099 | In distribution | ||
| 450092 | In distribution | ||
| 450130 | In distribution | ||
| 450041 | 100 | In distribution | |
| 450063 | 100 | In distribution | |
| 450090V1 | In distribution | ||
| 450085 | In distribution | ||
| 450062 | 100 | In distribution | |
| 450128 | In distribution | ||
| 450241 | 100 | In distribution | |
| 450125 | In distribution | ||
| 450161V1 | In distribution | ||
| 450061 | 100 | In distribution | |
| 450226V1 | In distribution | ||
| 450161 | In distribution | ||
| 450263D | 100 | In distribution | |
| 450086V1 | In distribution | ||
| 450073 | 100 | In distribution | |
| 450044 | 100 | In distribution | |
| 450081V1 | In distribution | ||
| 450084 | In distribution | ||
| 450127 | In distribution | ||
| 450239V1 | In distribution | ||
| 450123 | In distribution | ||
| 450085V1 | In distribution | ||
| 450228V1 | In distribution | ||
| 450045 | 100 | In distribution | |
| 450160 | In distribution | ||
| 450160V1 | In distribution | ||
| 450122 | In distribution | ||
| 450092V1 | In distribution | ||
| 450098 | In distribution | ||
| 450084V1 | In distribution | ||
| 450230 | 50 | In distribution | |
| 450091V1 | In distribution | ||
| 450086 | In distribution | ||
| 450129 | In distribution | ||
| 450070 | 100 | In distribution | |
| 450081 | In distribution | ||
| 450091 | In distribution | ||
| 450076 | 100 | Withdrawn | |
| 450040 | 100 | Withdrawn | |
| 450235 | Withdrawn | ||
| 450228 | Withdrawn | ||
| 450239 | Withdrawn | ||
| 450097 | Withdrawn | ||
| 450043 | 100 | Withdrawn | |
| 450075 | 100 | Withdrawn | |
| 450042 | 100 | Withdrawn | |
| 450071 | 100 | Withdrawn | |
| 450095 | Withdrawn | ||
| 450226 | Withdrawn |
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
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Greiner BIO-ONE Gmbh | 510(k) number | 2024-11-19 | Class II | Process control | The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device. | 188,800 pcs | |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2013-02-01 | Class II | Other | The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece. | 192,000 pieces (192 cases) | 2013-10-29 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2012-04-02 | Class II | Process control | : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable. | 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263 | 2013-02-27 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2011-06-29 | Not classified | Other | At removal of the tube from the holder, the needle may dislodge and blood spill can occur. | 142,400 pieces | 2011-11-03 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2008-08-05 | Not classified | Process design | At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out. | 150,000 pcs | 2012-07-25 |
| Greiner BIO-ONE North America, Inc. | 510(k) number | 2008-05-16 | Not classified | Device Design | At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out. | 1,606,005 units | 2009-08-21 |
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.