FDA product code NZG: Bassinet, Hospital
NZG is the FDA product code for bassinet, hospital. It is a Class II device, regulated under 21 CFR 880.5145 and reviewed by the General Hospital panel. Devices under NZG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for NZG devices.
Definition
Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery.
Classification
| Field | Value |
|---|---|
| Device name | Bassinet, Hospital |
| Device class | Class II |
| Regulation | 21 CFR 880.5145 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for NZG devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-10-10.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code NZG?
NZG is the FDA product code for bassinet, hospital. It is a Class II device, regulated under 21 CFR 880.5145 and reviewed by the General Hospital panel.
What device class is NZG?
Class II, regulation 21 CFR 880.5145. Typical premarket route: 510(k) exempt.
Have NZG devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-10-10.
Next steps
- Run an FDA pathway report with predicate devices for product code NZG
- Run a recall and safety report across every NZG manufacturer
- Watch product code NZG 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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