Clever Choice Comfort EZ
Insulin Pen Needle 5/32 inch 4mm length and 33 gauge
71manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
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 | Simple Diagnostics, United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Complaint-file establishment |
| Record published | 2016-08-11 |
| Record revised | 2019-08-30 (version 3) |
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 |
| Packaging | Case of 30, case of 60, case of 5 |
| Sizes | Needle gauge 29 to 33 G; length 4 to 8 mm; length 0.25 to 0.5 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Insulin Pen 32G 1/4″ | Needle Gauge 32 G | 100 | In distribution |
| Insulin Pen 31G 1/4″ 6mm | Needle Gauge 31 G | 100 | In distribution |
| Insulin Pen 29G 1/2″ | Length.5 in | 100 | In distribution |
| Insulin Pen 31G 3/16″ | Length 5 mm | 100 | In distribution |
| Insulin Pen 31G 1/4″ – 50ct | Needle Gauge 31 G | 50 | In distribution |
| Insulin Pen 33G 4mm 5/32″ | Length 4 mm | 100 | In distribution |
| Insulin Pen 32G 1/4″ – 50ct | Needle Gauge 32 G | 50 | In distribution |
| Insulin Pen 32G 3/16″ – 50ct | Needle Gauge 32 G | 50 | In distribution |
| Insulin Pen 33G 5mm | Needle Gauge 33 G | 100 | In distribution |
| Insulin Pen 33G 5/32″ | Needle Gauge 33 G | 100 | In distribution |
| Insulin Pen 32G 5/32″ | Needle Gauge 32 G | 100 | In distribution |
| Insulin Pen 31G 3/16″ – 50ct | Needle Gauge 31 G | 50 | In distribution |
| Insulin Pen 31G 5/16″ | Length 8 mm | 100 | In distribution |
| Insulin Pen 32G 3/16″ | Needle Gauge 32 G | 100 | In distribution |
| Insulin Pen 33G 6mm | Needle Gauge 33 G | 100 | In distribution |
| Insulin Pen 32G 5/32″ – 50ct | Needle Gauge 32 G | 50 | In distribution |
| Insulin Pen 31G 5/16″ – 50ct | Needle Gauge 31 G | 50 | 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 |
|---|---|
| K121632 | 2012-08-10 |
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.