BD Nano 2nd Gen
BD Nano 2nd Gen is a pen needle for subcutaneous drug injection with a compatible pen injector. It has a 32 gauge, 4 mm stainless-steel cannula with a five-bevel tip. The assembly includes…
BD Nano 2nd Gen is a pen needle for subcutaneous drug injection with a compatible pen injector. It has a 32 gauge, 4 mm stainless-steel cannula with a five-bevel tip. The assembly includes a base, inner needle shield and wide outer cover.
The needle is inserted manually. Its hub and protective covers are polypropylene, and the cannula carries medical-grade lubricant. A paper tear-drop label forms part of the protective assembly. The device is supplied sterile after gamma irradiation for single use.
Listed Item
BD Nano 2nd Gen Pen Needles, 4mm, 32G, 5bevel, UTW
Documented Material Configuration
The described update introduces an alternate supplier of the polypropylene resin used in the hub and covers. It retains the needle gauge, length, intended use and component layout. The disposable needle works with the drug pen rather than storing or metering the drug dose itself.
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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K212015 |
| Record published | 2023-08-09 |
| Record revised | 2025-05-12 (version 5) |
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, manufacturing date |
| Packaging | Case of 12 |
| Sizes | Length 4 mm; needle gauge 32 G |
| Distribution end date | 2028-06-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 320574 | Length 4 mm | 90 | 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 |
|---|---|
| K223286 | 2022-12-28 |
| K213478 | 2022-06-28 |
| K213156 | 2021-12-08 |
| K212015 | 2021-11-19 |
| K181730 | 2019-03-01 |
| K182320 | 2018-12-20 |
| K170824 | 2018-08-20 |
| K162516 | 2016-12-09 |
| K161553 | 2016-07-06 |
| K161170 | 2016-05-27 |
| K110703 | 2011-07-27 |
| K100005 | 2010-04-15 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Embecta Medical II LLC | 510(k) number | 2024-06-18 | Class II | Process control | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed. | 185900 |
| Embecta Medical II LLC | 510(k) number | 2023-07-26 | Not classified | Nonconforming Material/Component | Retrospectively reported: Pen needles labeled ‘For Investigational Use Only’ were inadvertently distributed as commercially marketed devices. | 4300 Final Count (in EA) |
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.