Primo Inc
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Primo Inc is a medical device manufacturer, with 232 devices listed in FDA GUDID (FDA Class I) as of 13 Nov 2026.
- Devices
- 232
Registry facts
- Registries
- FDA GUDID 232
- Device classes
- FDA Class I 232
- Identifiers
- DUNS 958758146
What Primo Inc makes
Primo Inc manufactures single-use and reusable patient positioning and protective devices, including heel protectors like the Guardian Mid-Calf Heel Protector and Buck’s Traction Boot, as well as transfer/turning sheets such as the Glide & Guide Turn Sheet. Their portfolio also includes splints like the Wrist Drop with U-Cuff Hand Splint, cushions such as the wheelchair seat cushion, and reusable patient positioners like the Well Leg Holder and Wipe Down Body Wedge. Additional products include abdominal binders and friction/impact protectors for arms, designed to reduce injury risk during patient handling or mobility.
All devices produced by Primo Inc fall under Class I regulatory classification in the U.S., with each product listed in the FDA’s UDI (Unique Device Identification) database. The company operates within U.S. regulatory frameworks, ensuring compliance with mandatory labeling and manufacturing requirements for low-risk medical devices.
Catalogue
Search and filter all 232 devicesShowing 1-50 of 232
Company details
- DUNS number
- 958758146
Frequently asked questions
How many devices does PRIMO INC have in the registry?
The registry currently lists 232 devices for PRIMO INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list PRIMO INC's devices?
Among its 50 most recently registered devices, PRIMO INC has devices listed in FDA GUDID (50 devices).
What risk classes do PRIMO INC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for PRIMO INC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from PRIMO INC in the registry?
The most recently registered devices listed for PRIMO INC include PRIMOBoot, Red/Khaki - Standard BAB8000, Buck's Traction Boot BT01-12, Guardian Mid-Calf Heel Protector HP211C and Well Leg Holder WLH01.