FDA product code NNL: Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile
NNL is the FDA product code for container, specimen mailer and storage, temperature controlled, non-sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Pathology panel. Devices under NNL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 864.3250 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NNL devices
openFDA lists no recalls for product code NNL.
Frequently asked questions
What is FDA product code NNL?
NNL is the FDA product code for container, specimen mailer and storage, temperature controlled, non-sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Pathology panel.
What device class is NNL?
Class I, regulation 21 CFR 864.3250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NNL
- Run a recall and safety report across every NNL manufacturer
- Watch product code NNL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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