BD Microtainer® Contact-Activated Lancet
BD Microtainer Contact-Activated Lancet obtains small capillary blood specimens using a retracting stainless steel needle or blade. The sterile, single-use device activates when pressure is…
BD Microtainer Contact-Activated Lancet obtains small capillary blood specimens using a retracting stainless steel needle or blade. The sterile, single-use device activates when pressure is applied against the skin puncture site.
The needle or blade remains concealed and sterile until the protective tab cap is removed. After puncture it retracts permanently into the housing, and the device disables itself to prevent reuse.
Listed Item
LANCET CONT-ACT BLUE 1.5MM x 2.0MM US
Activation Assembly
The internal mechanism combines a drive spring, lever, needle carrier and return spring inside a shielded housing. The contact-triggered action and nonredeployable sharp are intended to limit accidental fingerstick and contamination during sampling.
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 | Becton, Dickinson AND Company, United States |
|---|---|
| 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 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K223243 |
| Record published | 2023-03-15 |
| Record revised | 2024-07-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Room Temperature |
| Packaging | Case of 10 |
| Sizes | Needle gauge 21 to 30 G; length 1.5 mm |
| Distribution end date | 2024-01-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 366577 | Needle Gauge 21.00 G | 200 | In distribution |
| 366576 | Needle Gauge 30.00 G | 200 | In distribution |
| 366578 | Length 1.50 mm | 200 | In distribution |
| 366592 | Needle Gauge 30.00 G | 200 | Withdrawn |
| 366593 | Needle Gauge 21.00 G | 200 | Withdrawn |
| 366594 | Length 1.50 mm | 200 | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223243 | 2022-12-16 |
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.