HumaPen® Luxura™ HD – Sample
HumaPen Luxura HD is a reusable mechanical pen injector for self-injection of Lilly insulin from 3 mL cartridges. The listed sample-use version uses a separately supplied, detachable…
HumaPen Luxura HD is a reusable mechanical pen injector for self-injection of Lilly insulin from 3 mL cartridges. The listed sample-use version uses a separately supplied, detachable disposable pen needle.
The user selects a dose from 0.5 to 30 units in half-unit steps. The pen uses a piston-syringe mechanism and allows dose dialing in either direction.
Listed Item
HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL insulin cartridges. Designated for sample use.
Dose Selection
Audible clicks accompany each dose increment. The cartridge and needle are separate from the reusable pen, so the device provides the dosing mechanism for the compatible insulin cartridge rather than supplying the medicine itself.
Who Else Makes It
Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston
Record
| Listed by | Eli Lilly and Co., United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| 510(k) | K100988 |
| Record published | 2017-05-25 |
| Record revised | 2024-04-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS9675 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 228 |
| Medallion® | Merit Medical Systems, Inc. | 223 |
| Merit Medical® | Merit Medical Systems, Inc. | 192 |
| Monoject | Cardinal Health | 188 |
| Medline | Medline Industries, Inc. | 127 |
| EasyTouch | MHC Medical Products | 122 |
| Medline Industries, Inc. | Medline Industries, Inc. | 99 |
| Arrow | Teleflex Medical LLC | 94 |
| Ceros | Rhino Medical Supply Inc | 92 |
| Enteral Feeding | Medela LLC | 87 |
| Monoject | Cardinal Health 200, LLC | 83 |
| HSW Soft-Ject® | Henke-Sass Wolf, Gmbh. | 80 |
Showing 12 of 913. All products under Syringe, Piston
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160668 | 2016-06-03 |
| K151686 | 2015-12-30 |
| K142518 | 2015-06-05 |
| K100988 | 2010-08-17 |
| K053563 | 2006-04-07 |
| K982842 | 1998-09-25 |
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.