PneumoDart
Superior Tension Pneumothorax Decompression Needle
Who Else Makes It
Concentrated in Zhejiang (9), Jiangsu (7), Shanghai (6). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Shanghai Kindly Enterprise Development Group Co., Ltd. | Jiading | Shanghai | Contract manufacturer | 11 |
| Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | Taihu | Anhui | Contract manufacturer | 8 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
Showing 12 of 37. All 37 manufacturers in China registered for Needle, Aspiration And Injection, Disposable
Record
| Listed by | Tytek Medical Inc, United States |
|---|---|
| FDA product code | GAA |
| Device type | Needle, Aspiration And Injection, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-10-03 |
| Record revised | 2025-06-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TM-317 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 298 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 148 |
| Zavation | Zavation | 121 |
| Whiterose Micro Cannula | UC Medical | 38 |
| Monoject | Cardinal Health | 33 |
| MagniCore | Cook Incorporated | 29 |
| Breast localisation needle | Möller Medical GmbH | 29 |
| CytoCut | M.D.L. S.R.L. | 28 |
| Chiba Needle Marked | Remington Medical, Inc. | 26 |
| Walcott Rx Products | Psi/Eye-Ko, Inc. | 24 |
| Breast Localization Needles | Argon Medical Devices, Inc. | 23 |
| Fine Needle Aspiration | Mermaid Medical A/S | 22 |
Showing 12 of 183. All products under Needle, Aspiration And Injection, Disposable
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Tytek Medical Inc | UDI-DI | 2020-10-05 | Class II | Device Design | Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location | 22,026 units | 2026-03-13 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-10-05 | Class II | Device Design | Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location | 4400 units | 2026-03-13 |
| 2020-10-05 | Class II | Device Design | Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location | 439146 units | 2026-03-13 |
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.