FDA product code NRV: Implantable Radio Frequency Transponder System

NRV is the FDA product code for implantable radio frequency transponder system. It is a Class II device, regulated under 21 CFR 880.6300 and reviewed by the General Hospital panel. Devices under NRV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

An implantable microtransponder system intended to facilitate access to identification and health information in humans. It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader. The microtransponder stores only a unique electronic identification number (id). The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient

Classification

Recalls for NRV devices

openFDA lists no recalls for product code NRV.

Frequently asked questions

What is FDA product code NRV?

NRV is the FDA product code for implantable radio frequency transponder system. It is a Class II device, regulated under 21 CFR 880.6300 and reviewed by the General Hospital panel.

What device class is NRV?

Class II, regulation 21 CFR 880.6300. Typical premarket route: 510(k) exempt.

Next steps

• Run an FDA pathway report with predicate devices for product code NRV
• Run a recall and safety report across every NRV manufacturer
• Watch product code NRV 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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