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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 2 of 24
DeviceModel / ReferenceRegistriesClassStatus
Regard™ LD0863
FDA UDI
Class IIUnknown
Regard™ GS0292
FDA UDI
Class IIUnknown
Regard™ 303398
FDA UDI
Class IIActive
Regard™ GS0984
FDA UDI
Class IIUnknown
Regard™ GS0829
FDA UDI
Class IUnknown
Regard™ GS1007
FDA UDI
Class IIUnknown
Regard™ DBPSMADLT-REG
FDA UDI
Class IIActive
Regard™ HT0338
FDA UDI
Class IIUnknown
Regard™ LD0608
FDA UDI
Class IIUnknown
Regard™ LPSPNG18X4DX5-REG
FDA UDI
Class IActive
Regard™ OR0836
FDA UDI
Class IUnknown
Regard™ GS0694
FDA UDI
Class IIUnknown
Regard™ GS0582
FDA UDI
Class IIUnknown
Regard™ HT0391
FDA UDI
Class IIUnknown
Regard™ OB0166
FDA UDI
Class IIUnknown
Regard™ HT0386
FDA UDI
Class IIUnknown
Regard™ CV0552
FDA UDI
Class IIUnknown
Regard™ GS0780
FDA UDI
Class IIUnknown
Regard™ HT0544
FDA UDI
Class IIUnknown
Regard™ CV0978
FDA UDI
Class IIUnknown
Regard™ GASPG4X4P16S-REG
FDA UDI
Class IActive
Regard™ GS0241
FDA UDI
Class IIUnknown
Regard™ RBPADLT-REG
FDA UDI
Class IIActive
Regard™ GS0055
FDA UDI
Class IIUnknown
Regard™ RBPSMADLT-REG
FDA UDI
Class IIActive
Regard™ GS0649
FDA UDI
Class IIUnknown
Regard™ STKIMPPT12X54NS-REG
FDA UDI
Class IActive
Regard™ PL0023
FDA UDI
Class IUnknown
Regard™ OR0989
FDA UDI
Class IUnknown
Regard™ OR0628
FDA UDI
Class IUnknown
Regard™ GS0573
FDA UDI
Class IIUnknown
Regard™ LD0596
FDA UDI
Class IIUnknown
SurgiPlus 66-3130-S
FDA UDI
Class IIActive
Regard™ GS0810
FDA UDI
Class IIUnknown
Regard™ OR0733
FDA UDI
Class IUnknown
Regard™ GY0939
FDA UDI
Class IIUnknown
Regard™ CV0852
FDA UDI
Class IIUnknown
Regard™ 70412ROI
FDA UDI
Class IActive
Regard™ GS0445
FDA UDI
Class IIUnknown
Regard™ STKCT1PL4ST-REG
FDA UDI
Class IActive
Regard™ HT0468
FDA UDI
Class IIUnknown
Regard™ GS0408
FDA UDI
Class IIUnknown
Regard™ NU1048
FDA UDI
Class IUnknown
Regard™ EY0036
FDA UDI
Class IIUnknown
Regard™ OR0841
FDA UDI
Class IUnknown
Regard™ OR0761
FDA UDI
Class IUnknown
Regard™ OR0020
FDA UDI
Class IUnknown
Regard™ OR0356
FDA UDI
Class IUnknown
Regard™ OR0523
FDA UDI
Class IUnknown
Regard™ GS0411
FDA UDI
Class IIUnknown

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