Data / Medical devices / Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile
Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile (NNL): 13 FDA-registered makers in 6 countries
13 establishments in 6 countries are registered with the FDA to make Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile (product code NNL, Class 1, 21 CFR 864.3250). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NNL
- Device class
- 1
- Regulation
- 864.3250
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 2 |
| India | 2 |
| South Korea | 1 |
| Germany | 1 |
| Mexico | 1 |
Makers of Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aero-Med LLC | East Hartford, CT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSL Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CSafe Global | Dayton, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| International Haotian Technology Co., Ltd. | Xiamen Fujian, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimeas Instruments | Ambala Cantt Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nalge Nunc International Corporation | Rochester, NY, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarstedt AG & Co. KG | NUMBRECHT North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sipcon Technologies Private Limited | Ambala Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Dot Printer Inc. | Irvine, CA, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermo Fisher Scientific (Monterrey) | Apodaca Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gongdong Medical Technology Co., Ltd | TAIZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.