← Product Code [NRV](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/NRV) · DEN040007

# VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER (DEN040007)

_Digital Angel Corporation · NRV · Oct 12, 2004 · General Hospital · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/NRV/DEN040007

## Device Facts

- **Applicant:** Digital Angel Corporation
- **Product Code:** [NRV](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/NRV.md)
- **Decision Date:** Oct 12, 2004
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 880.6300
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

An implantable radiofrequency transponder system for patient identification and health information is a device intended to enable access to secure patient identification and corresponding health information. This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code that is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database.

## Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information.” See § 880.1(e) for the availability of this guidance document. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/NRV/DEN040007](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/NRV/DEN040007)

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