FDA product code OJL: Insulin Vial Protector/Holder
OJL is the FDA product code for insulin vial protector/holder. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel. Devices under OJL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
The device is intended to protect an insulin vial or vials
Classification
| Field | Value |
|---|---|
| Device name | Insulin Vial Protector/Holder |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| Review panel | HO — General Hospital |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for OJL devices
openFDA lists no recalls for product code OJL.
Frequently asked questions
What is FDA product code OJL?
OJL is the FDA product code for insulin vial protector/holder. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel.
What device class is OJL?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OJL
- Run a recall and safety report across every OJL manufacturer
- Watch product code OJL 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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