Autokeeper
Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in conjunction with insulin pen injectors. Pen needles are used by consumers, caregivers and…
Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in conjunction with insulin pen injectors. Pen needles are used by consumers, caregivers and health care professionals. They are offered in six gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm and 8mm). This device is sterile (EO gas sterilization). Additionally, the attached safety shield automatically locks in place and is intended to help reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. This device is assembly consists of Sterile cap, Needle cap, Middle cap, Spring, Needle, Safety shield, hub and sterile paper.
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Medexel Co., Ltd., South Korea |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K172095 |
| Record published | 2020-05-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 1 to 30 °C |
| Packaging | Case of 10, master case of 4, case of 4, master case of 10 |
| Sizes | Length 4 mm; needle gauge 29 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Safety Pen Needle 34G x 8mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 32G x 5mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 34G x 6mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 30G x 6mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 29G x 5mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 29G x 6mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 31G x 5mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 32G x 6mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 30G x 8mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 29G x 8mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 31G x 8mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 33G x 6mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 34G x 5mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 33G x 8mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 29G x 8mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 31G x 4mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 30G x 5mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 32G x 8mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 33G x 4mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 31G x 6mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 29G x 4mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 34G x 4mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 33G x 5mm 100PCS | Length 4 mm | In distribution |
| Safety Pen Needle 32G x 4mm 100PCS | Length 4 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health | 124 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172095 | 2018-07-24 |
| K152410 | 2016-02-02 |
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.