Preventice Services, LLC
Country not established
Preventice Services, LLC is a medical device manufacturer, with 6 devices listed in FDA GUDID and 1 FDA recall as of 13 Nov 2026.
- Devices
- 6
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 6
- FDA recalls
- Identifiers
- DUNS 176104664
At a glance
Market reach
- United States
- FDA recalls
What Preventice Services, LLC makes
Preventice Services, LLC manufactures electrocardiography (ECG) telemetric monitoring systems designed for remote patient monitoring. These include portable kits for continuous heart rhythm monitoring, such as the BodyGuardian One, Mortara H3+, and BodyGuardian Heart systems, as well as smaller handheld devices like the BodyGuardian Mini and Mini Plus. The PER900 system is also part of the portfolio, offering remote ECG monitoring capabilities for clinical use.
The company’s devices are classified under the FDA’s Unique Device Identification (UDI) system and fall within Class II regulatory classification for electrocardiographic monitoring systems. These products are listed in the FDA’s UDI database and are intended for use in the United States. No additional regulatory bodies or registries are specified for these devices.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Company details
- DUNS number
- 176104664
FDA recalls
FDA recall records list 1 recall initiated by Preventice Services, LLC, initiated on 2019-08-06. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 6 Aug 2019 Z-2479-2020 Class II Terminated The device data being collected and transferred to the monitoring center may not be accurate due to nonvalidated association between the phone software and the heart monitors, therefore, the patient's report should not be used to evaluate their condition.
Frequently asked questions
How many devices does Preventice Services, LLC have in the registry?
The registry currently lists 6 devices for Preventice Services, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Preventice Services, LLC's devices?
Among its 6 most recently registered devices, Preventice Services, LLC has devices listed in FDA GUDID (6 devices).
Are there FDA recall records for Preventice Services, LLC?
FDA recall records list 1 recall initiated by Preventice Services, LLC, the most recent initiated on 6 Aug 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Preventice Services, LLC in the registry?
The most recently registered devices listed for Preventice Services, LLC include BodyGuardian One Remote Monitoring System Kit 2001KIT-BGONE, Mortara H3+ Monitoring System Kit 2001KIT-MORTARA, BodyGuardian Heart Remote Monitoring System Kit 2001KIT-BodyGuardian and PER900 Monitoring System Kit 2001KIT-PER900.