Aero-Med
Neuropath Specimen Kit, Transport, Stanford Medical Center Only
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| International Haotian Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
Record
| Listed by | Aero-MED LLC, United States |
|---|---|
| FDA product code | NNL |
| Device type | Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-03-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Packaging | Case of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CA7225A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mawi DNA Technologies | Mawi DNA Technologies | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| MagBio Genomics, Inc. | Magbio Genomics Inc. | 4 |
| ACS Combo-B Incubator | BSL Co., Ltd. | 2 |
| Cool transport container | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| ClinicoLab | Surgyco LLC | 1 |
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.