ONE-Care PRO Safety Lancets, Button-Activated, 25g X 1.6mm
Catalogue number ONE-CARE PRO Safety Lancets, Button-Acti, listed by MediVena, LLC, under Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature. 36 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (11), Zhejiang (9), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Huaian Hening Medical Instruments Co., Ltd. and its Subsidiary Huaian Junran IMP.&EXP. Trading Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 4 |
| Jetcrown Industrial (Dong Guan) Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
Showing 12 of 36. All 36 manufacturers in China registered for Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Record
| Listed by | MediVena, LLC |
|---|---|
| FDA product code | FMK |
| Device type | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4850 |
| 510(k) | K222408 |
| Record published | 2024-02-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 32 to 104 °F |
| Packaging | Case of 20 |
| Sizes | Needle gauge 25 G; length 1.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ONE-CARE PRO Safety Lancets, Button-Activated, 25G x 1.6mm | Needle Gauge 25 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 35 |
| Verifine | Promisemed Medical Devices Inc. | 32 |
| McKesson | Mckesson Medical-Surgical Inc. | 29 |
| Medline | Medline Industries, Inc. | 28 |
| SurgiLance Safety Lancet | Medipurpose PTE. Ltd. | 26 |
| Twist Lancet (32G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 25 |
| xinle | Hebei Xinle SCI&Tech Co., Ltd. | 24 |
| Twist Lancet (31G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 24 |
| Twist Lancet (33G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 23 |
| Twist Lancet (30G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 19 |
| Unistik 3 | Owen Mumford Limited | 18 |
| Safety Lancet (21GBlade) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 16 |
Showing 12 of 345. All products under Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
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.