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RESOURCE 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
—
Website
—
LinkedIn
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Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
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DUNS Number
945020902

Catalogue (1170)

Page 18 of 24
DeviceModel / ReferenceRegistriesClassStatus
Regard™ GS1065
FDA UDI
Class IIUnknown
Regard™ A3SRGREINFST2XL-REG
FDA UDI
Class IIActive
Regard™ EY0099
FDA UDI
Class IIUnknown
Regard™ GS0681
FDA UDI
Class IIUnknown
Regard™ NU0259
FDA UDI
Class IUnknown
Regard™ HT0267
FDA UDI
Class IIUnknown
Regard™ HT0990
FDA UDI
Class IIUnknown
Regard™ OR0542
FDA UDI
Class IUnknown
Regard™ NU0504
FDA UDI
Class IUnknown
Regard GS0904
FDA UDI
Class IIUnknown
Regard™ OR0679
FDA UDI
Class IUnknown
Regard™ CV0805
FDA UDI
Class IIUnknown
Regard™ GY0486
FDA UDI
Class IIUnknown
Regard™ NU0961
FDA UDI
Class IUnknown
Regard™ OR0415
FDA UDI
Class IUnknown
Regard™ HT0475
FDA UDI
Class IIUnknown
Regard™ GY0487
FDA UDI
Class IIUnknown
Regard™ GS0839
FDA UDI
Class IIUnknown
Regard™ OR0150
FDA UDI
Class IUnknown
Regard™ OB0988
FDA UDI
Class IIUnknown
Regard™ ET0927
FDA UDI
Class IUnknown
Regard™ OB0103
FDA UDI
Class IIUnknown
Regard™ UR0818
FDA UDI
Class IIUnknown
Regard™ PL0126
FDA UDI
Class IUnknown
Regard™ LD0506
FDA UDI
Class IIUnknown
Regard™ NU0303
FDA UDI
Class IUnknown
Regard™ HT0907
FDA UDI
Class IIUnknown
Regard™ BAGA75X4RP-REG
FDA UDI
Class IActive
Regard™ LD0477
FDA UDI
Class IIUnknown
Regard™ LD0576
FDA UDI
Class IIUnknown
Regard™ SP1079
FDA UDI
Class IIUnknown
Regard™ HT0671
FDA UDI
Class IIUnknown
Regard™ UR0739
FDA UDI
Class IIUnknown
Regard™ ABG3CCBLNT-REG
FDA UDI
Class IActive
Regard™ GY1066
FDA UDI
Class IIUnknown
Regard™ CVRBTTIEXL-REG
FDA UDI
Class IActive
Regard™ 303406
FDA UDI
Class IIActive
Regard™ HT0183
FDA UDI
Class IIUnknown
Regard™ ABG3CC23G-REG
FDA UDI
Class IActive
Regard™ OR0546
FDA UDI
Class IUnknown
Regard™ HT0607
FDA UDI
Class IIUnknown
Regard™ LD0081
FDA UDI
Class IIUnknown
Regard™ OR0765
FDA UDI
Class IUnknown
Regard™ LD0618
FDA UDI
Class IIUnknown
Regard™ OR0730
FDA UDI
Class IUnknown
Regard™ LD0370
FDA UDI
Class IIUnknown
Regard™ GS0121
FDA UDI
Class IIUnknown
Regard™ OR0031
FDA UDI
Class IUnknown
Regard™ NU1018
FDA UDI
Class IUnknown
Regard™ T100AC-PHYSIO
FDA UDI
Class IIActive

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