Cardinal Health
Cardinal Health’s contact-activated phlebotomy lancet is a single-use blood-sampling device that punctures skin to obtain a drop for diagnostic testing. The filed item identifies a…
Cardinal Health’s contact-activated phlebotomy lancet is a single-use blood-sampling device that punctures skin to obtain a drop for diagnostic testing. The filed item identifies a finger-activated, low-flow, 25-gauge configuration; the lancet performs the puncture step, while a separate test or sampler collects and analyzes the blood.
Cardinal’s catalog describes its contact-activated lancet family with a ribbed safety tab, a recessed finger housing and gentle-pressure activation. The catalog groups several gauge and flow options within that product family.
Listed Item
Lancet Phlebotomy 1.8MM OD 25GA Contact Finger Activated LOW Flow
Sampling Device
The recessed housing provides a finger area for the contact-activated design, and the ribbed safety tab is removed by twisting according to the manufacturer’s catalog. These details describe the family design.
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 | Cardinal Health 200, LLC, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-04-12 |
| Record revised | 2025-09-22 (version 6) |
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 -20 to 65 °C; Storage environment humidity 10 to 90 % RH |
| Packaging | Case of 20, case of 10, case of 40, box of 50, case of 18, case of 24 |
| Sizes | Depth 0.85 to 2 mm; needle gauge 21 to 28 G; length 1.75 to 2.5 mm |
| Distribution end date | 2026-09-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SLDF100 | 100 | In distribution | |
| GHT10X50 | In distribution | ||
| SLCALF200 | 200 | In distribution | |
| GHN10X50 | In distribution | ||
| SLPB21200 | Depth 2 mm | 200 | In distribution |
| SLLF200 | 200 | In distribution | |
| CHBHLP100 | 100 | In distribution | |
| GHMP10X50 | In distribution | ||
| SLULF200 | 200 | In distribution | |
| GHN4X250 | Length 2.5 mm | In distribution | |
| SLCA23200 | 200 | In distribution | |
| SLAD23100 | 100 | In distribution | |
| SLHF200 | 200 | In distribution | |
| SLCAMF200 | 200 | In distribution | |
| GHP5X200 | In distribution | ||
| SLPB25200 | Depth 1.6 mm | 200 | In distribution |
| SLDF200 | 200 | In distribution | |
| SLPBHN200 | 200 | In distribution | |
| SLCA21200 | 200 | In distribution | |
| SLCA28200 | 200 | In distribution | |
| SLPB28200 | Needle Gauge 28 G | 200 | In distribution |
| SLMF200 | 200 | In distribution | |
| GHP4X250 | Depth 0.85 mm | In distribution | |
| SLCANF200 | 200 | In distribution | |
| CHBHLN100 | 100 | In distribution | |
| SLCA30200 | 200 | In distribution | |
| SLHF100 | 100 | In distribution | |
| SLPBLF200 | 200 | In distribution | |
| GHP10X50 | In distribution | ||
| GHN5X200 | In distribution | ||
| SLPBHF200 | 200 | In distribution | |
| SLMF100 | 100 | Withdrawn | |
| SLULF100 | 100 | Withdrawn | |
| SLPBMF200 | 200 | Withdrawn | |
| SLLF100 | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Safety Lancet (18GBlade) | 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.