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US
Last updated May 23, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Primo Inc manufacture?
Primo Inc specializes in patient positioning and protective devices, including single-use and reusable options. Their portfolio covers heel protectors like the Guardian Mid-Calf Heel Protector and Buck’s Traction Boot, patient transfer/turning sheets such as the Glide & Guide Turn Sheet, hand/finger splints like the Wrist Drop with U-Cuff Hand Splint, wheelchair seat cushions, reusable patient positioners (e.g., Well Leg Holder), abdominal binders, and arm friction/impact protectors. These devices are designed to support patient mobility, reduce injury risk, and enhance comfort during care.
Where is Primo Inc based, and does it operate internationally?
Primo Inc is based in the United States. While the provided data does not specify international operations, the company’s focus is on U.S. regulatory compliance for its devices, which are classified under the FDA’s framework. This suggests its primary market and regulatory scope is within the U.S., though additional markets cannot be confirmed without further details.
Which regulatory registries or databases list Primo Inc’s devices?
Primo Inc’s devices are listed in the FDA’s UDI (Unique Device Identification) database. The UDI system is a mandatory requirement for Class I devices in the U.S., ensuring traceability and compliance with regulatory standards. This listing helps healthcare providers and regulators identify and verify the devices’ details, such as manufacturer information and classification.
How are Primo Inc’s devices classified under U.S. regulations?
All devices manufactured by Primo Inc fall under Class I regulatory classification in the U.S. Class I devices are generally considered low-risk and typically require only general controls (e.g., proper labeling, manufacturing practices) to ensure safety and effectiveness. This classification aligns with their product categories, such as heel protectors, transfer sheets, and splints, which are designed for minimal risk to patients when used as intended.
Why are Primo Inc’s devices listed in the FDA’s UDI database?
The FDA’s UDI database is a requirement for all Class I medical devices in the U.S. to ensure transparency, traceability, and compliance with regulatory standards. Listing in the UDI system provides standardized identification for Primo Inc’s devices, including details like the manufacturer’s name, device description, and regulatory classification. This helps healthcare facilities, insurers, and regulators quickly access accurate information about the devices, reducing errors and improving patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 958758146
Catalogue (232)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Guardian Mid-Calf Heel Protector | HP211Y | FDA UDI | Class I | Active |
| Wheelchair Backpack | PM100 | FDA UDI | Class I | Active |
| Wipe Down Body Wedge w/Handle - Bariatric | BPW02FC | FDA UDI | Class I | Active |
| Glide & Guide Turn System Kit | GGTS02B | FDA UDI | Class I | Active |
| Anti-Rotational Wedge for HeelShield | ARW03 | FDA UDI | Class I | Active |
| Preventive Pad | PPWD281645 | FDA UDI | Class I | Active |
| Glide & Guide Turn Sheet Select | GGS5660F | FDA UDI | Class I | Active |
| Economy Glide & Guide Turn Sheet | GGE3660 | FDA UDI | Class I | Active |
| Glide & Guide Turn System Kit Economy | GGTS03 | FDA UDI | Class I | Active |
| Glide & Guide Turn System Kit | GGTS02 | FDA UDI | Class I | Active |
| PRIMOBoot, Burn - Bariatric | BABBRN01-B | FDA UDI | Class I | Active |
| PRIMOBoot, Gold/Navy - Standard | BAB14 | FDA UDI | Class I | Active |
| Foam Body Wedge - Standard | BPW01F | FDA UDI | Class I | Active |
| Synthetic Sheepskin Bed Overlay | SS3040 | FDA UDI | Class I | Active |
| Air Float Static Air Mattress Overlay | AF76343 | FDA UDI | Class I | Active |
| Glide & Guide Turn Sheet Select | GGS3660SSF | FDA UDI | Class I | Active |
| PRIMOBoot Long Term Care - Standard | BABLTC | FDA UDI | Class I | Active |
| PRIMOBoot, Kelly Green/Khaki - Standard | BAB7000 | FDA UDI | Class I | Active |
| Wrist Drop w/ U-Cuff Hand Splint | WDS01RS | FDA UDI | Class I | Active |
| Guardian Mid-Calf Heel Protector | HP211P | FDA UDI | Class I | Active |
| Glide & Guide Turn Sheet | GGS5660 | FDA UDI | Class I | Active |
| Glide & Guide Turn System Kit | GGTS01B | FDA UDI | Class I | Active |
| Resting Hand Splint | RHS02LL | FDA UDI | Class I | Active |
| Micro-Suede Body Wedge - Standard | BPW03F | FDA UDI | Class I | Active |
| Preventive Pad | PPWD381645 | FDA UDI | Class I | Active |
| Defender - Standard | HB100 | FDA UDI | Class I | Active |
| Wipe Down Body Wedge Set, Rounded | BPW11R | FDA UDI | Class I | Active |
| Heel/Elbow Protector | HEP01XL | FDA UDI | Class I | Active |
| HeelShield | HS51B | FDA UDI | Class I | Active |
| Resting Hand Splint | RHS01RXL | FDA UDI | Class I | Active |
| Economy Foam Heel Protector | HP301 | FDA UDI | Class I | Active |
| Glide & Guide Turn Sheet Select | GGS3660F | FDA UDI | Class I | Active |
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