OneTouch Delica Plus Lancing Device
The OneTouch Delica Plus Lancing Device obtains a small capillary blood sample from a fingertip for testing. It is a reusable, nonsterile device for one patient and is used with a…
The OneTouch Delica Plus Lancing Device obtains a small capillary blood sample from a fingertip for testing. It is a reusable, nonsterile device for one patient and is used with a compatible sterile lancet intended for a single puncture.
The device provides 13 depth settings to adjust the puncture depth. Its compatible lancets are available in 30-gauge and 33-gauge sizes. The reusable device guides the lancet rather than measuring glucose or analysing the blood sample itself.
Listed Item
Box of 1 Lancing Device and 10 Sterile Lancets 30 Gauge
Patient Use
The lancing system is intended for lay users in the home or a general environment. The lancet is disposed of after use, while the lancing device remains assigned to the same patient.
Who Else Makes It
Concentrated in Zhejiang (5), Tianjin (5), Jiangsu (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jetcrown Industrial (Dong Guan) Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Shanghai Carelife International Trading Co., Ltd. | Jinqiao Pudong | Shanghai | Specification developer | 11 |
| Sterilance Medical (Suzhou) Inc. | Suzhou | Jiangsu | Contract manufacturer | 8 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Showing 12 of 21. All 21 manufacturers in China registered for Multiple Use Blood Lancet For Single Patient Use Only
Record
| Listed by | Asahi Polyslider Co., Ltd., Japan |
|---|---|
| FDA product code | QRL |
| Device type | Multiple Use Blood Lancet For Single Patient Use Only |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4850 |
| 510(k) | K221546 |
| Record published | 2019-02-28 |
| Record revised | 2022-09-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Cardboard box of 24 |
| Sizes | Needle gauge 30 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02397301 | Needle Gauge 30 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Twist Lancet (23G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 24 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 18 |
| Twist Lancet (28G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 13 |
| Twist Lancet (30G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 12 |
| Twist Lancet (26G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 11 |
| Care Touch | Tianjin Huahong Technology Co., Ltd. | 10 |
| TysonBio | Shandong Lianfa Medical Plastic Products Co., Ltd. | 8 |
| Accu-Chek Fastclix | Roche Diabetes Care, Inc. | 8 |
| TRUEdraw | Trividia Health, Inc. | 7 |
| Right Lance | Beijing Ruicheng Medical Supplies Co., Ltd. | 5 |
| Huahong | Tianjin Huahong Technology Co., Ltd. | 5 |
| One +Step | Shandong Lianfa Medical Plastic Products Co., Ltd. | 4 |
Showing 12 of 103. All products under Multiple Use Blood Lancet For Single Patient Use Only
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221546 | 2022-08-23 |
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.