Pneumeric™ CapnoSpot™ Pneumothorax Decompression Indicator
The Pneumeric CapnoSpot Pneumothorax Decompression Indicator detects carbon dioxide in gas passing through a decompression needle or thoracostomy device. It provides a visual indication…
The Pneumeric CapnoSpot Pneumothorax Decompression Indicator detects carbon dioxide in gas passing through a decompression needle or thoracostomy device. It provides a visual indication during treatment of pneumothorax with suspected tension physiology, helping guide placement of the decompression device.
A polycarbonate tube contains carbon dioxide-sensitive paper that changes color when exposed to the gas. A distal male Luer connector attaches to the decompression device. A diaphragm permits one-way gas flow and prevents backflow. The indicator does not itself perform the needle puncture.
Connections and Supply
A proximal female Luer connector accepts accessories. The indicator is supplied nonsterile and is intended for a single use.
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 | Pneumeric, 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 |
| 510(k) | K223625 |
| Record published | 2024-11-25 |
| Record revised | 2026-03-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PDI-001 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223625 | 2023-03-28 |
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.