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Sign in to claim this brandRESOURCE OPTIMIZATION & INNOVATION, L.L.C.
US
Last updated May 23, 2026
What RESOURCE OPTIMIZATION & INNOVATION, L.L.C. makes
The company manufactures single-use protective apparel and medical accessories, including isolation gowns, scrub suits, and surgical gowns designed for healthcare settings. It also produces disposable electrode conductive skin pads, stockinette, arterial blood sampling kits, and woven gauze pads for wound care. Additionally, the portfolio includes single-use blood pressure cuffs for clinical monitoring.
The devices fall under FDA Class I, Class II, and Unclassified (U) regulatory categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States and adheres to applicable U.S. medical device regulations.
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 Resource Optimization & Innovation, L.L.C. manufacture?
Resource Optimization & Innovation, L.L.C. specializes in single-use medical devices primarily for healthcare settings. Their portfolio includes protective apparel like isolation gowns, scrub suits, and surgical gowns, as well as accessories such as disposable electrode conductive skin pads, stockinette, arterial blood sampling kits, woven gauze pads (non-antimicrobial), and single-use blood pressure cuffs. These products are designed for clinical use, patient safety, and procedural efficiency.
Where is Resource Optimization & Innovation, L.L.C. based?
The company is headquartered in the United States. While the specific location isn’t detailed, its operations and regulatory compliance align with U.S. medical device standards, including FDA requirements.
Which regulatory registries or databases list the devices made by Resource Optimization & Innovation, L.L.C.?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers and regulators, allowing them to identify and verify specific devices through standardized identifiers.
How are the devices manufactured by Resource Optimization & Innovation, L.L.C. classified under FDA regulations?
The devices fall into three regulatory classifications: Class I (generally low-risk devices requiring general controls), Class II (moderate-risk devices needing special controls), and Unclassified (U) for those not yet assigned a risk category. Classification depends on factors like intended use, potential risks, and patient exposure, as determined by FDA guidelines.
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
- 945020902
Catalogue (1170)
Page 19 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Regard™ | GU0587 | FDA UDI | Class II | Unknown |
| Regard™ | SHCVRXL2-REG | FDA UDI | Class I | Active |
| Regard™ | NU0909 | FDA UDI | Class I | Unknown |
| Regard™ | GS0643 | FDA UDI | Class II | Unknown |
| Regard™ | OR0976 | FDA UDI | Class I | Unknown |
| Regard™ | HT0227 | FDA UDI | Class II | Unknown |
| Regard™ | LD0116 | FDA UDI | Class II | Unknown |
| Regard™ | GASPG4X4P12S-REG | FDA UDI | Class I | Active |
| Regard™ | HT0614 | FDA UDI | Class II | Unknown |
| Regard™ | 303396 | FDA UDI | Class II | Active |
| Regard™ | CHMG38GNS800L-REG | FDA UDI | Class I | Active |
| Regard™ | NU1046 | FDA UDI | Class I | Unknown |
| Regard™ | HT0581 | FDA UDI | Class II | Unknown |
| Regard™ | GS0158 | FDA UDI | Class II | Unknown |
| Regard™ | CVRBTELSXL-REG | FDA UDI | Class I | Active |
| Regard™ | LD0154 | FDA UDI | Class II | Unknown |
| Regard™ | OR0903 | FDA UDI | Class I | Unknown |
| Regard™ | NU0299 | FDA UDI | Class I | Unknown |
| Regard™ | LD0358 | FDA UDI | Class II | Unknown |
| Regard™ | OB0667 | FDA UDI | Class II | Unknown |
| Regard™ | CV0670 | FDA UDI | Class II | Unknown |
| Regard™ | HT0641 | FDA UDI | Class II | Unknown |
| Regard™ | GS0302 | FDA UDI | Class II | Unknown |
| Regard™ | CV0425 | FDA UDI | Class II | Unknown |
| Regard™ | ET0936 | FDA UDI | Class I | Unknown |
| Regard™ | OB0122 | FDA UDI | Class II | Unknown |
| Regard™ | DSPSCRBPNTXXL-REG | FDA UDI | Class I | Active |
| Regard™ | EY0220 | FDA UDI | Class II | Unknown |
| Regard™ | GS0251 | FDA UDI | Class II | Unknown |
| Regard™ | SRGCPELS1-REG | FDA UDI | Class I | Active |
| Regard™ | HT0905 | FDA UDI | Class II | Unknown |
| Regard | A2ISOGXLNS-REG | FDA UDI | Class I | Active |
| Regard™ | CIRCUM2-REG | FDA UDI | Class II | Active |
| Regard™ | OR0413 | FDA UDI | Class I | Unknown |
| Regard™ | GS0470 | FDA UDI | Class II | Unknown |
| Regard™ | OR0424 | FDA UDI | Class I | Unknown |
| Regard™ | OR0350 | FDA UDI | Class I | Unknown |
| Regard™ | SHCVRXL3-REG | FDA UDI | Class I | Active |
| Regard™ | ORTWLBLSTD8-REG | FDA UDI | Class I | Active |
| Regard™ | OR0447 | FDA UDI | Class I | Unknown |
| Regard™ | ET0569 | FDA UDI | Class I | Unknown |
| Regard™ | OR0684 | FDA UDI | Class I | Unknown |
| Regard™ | GY1058 | FDA UDI | Class II | Unknown |
| Regard™ | OR0558 | FDA UDI | Class I | Unknown |
| Regard™ | GS0773 | FDA UDI | Class II | Unknown |
| Regard™ | NU0981 | FDA UDI | Class I | Unknown |
| Regard™ | AN0211 | FDA UDI | Class II | Unknown |
| Regard™ | DSPSCRBSHTGRL-RG | FDA UDI | Class I | Active |
| Regard™ | BFCAP21-REG | FDA UDI | Class I | Active |
| Regard™ | PEDIATRIC-PHYSIO | FDA UDI | Class II | Active |
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