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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
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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 5 of 24
DeviceModel / ReferenceRegistriesClassStatus
Regard™ STKIMP8X38ST-REG
FDA UDI
Class IActive
Regard™ PED-100
FDA UDI
Class IIActive
Regard™ OR0464
FDA UDI
Class IUnknown
Regard™ SLIDEBARI-REG
FDA UDI
Class IActive
Regard™ LD0910
FDA UDI
Class IIUnknown
Regard™ GS0218
FDA UDI
Class IIUnknown
Regard™ GS0467
FDA UDI
Class IIUnknown
Regard™ CV1059
FDA UDI
Class IIUnknown
Regard™ GASPGNA2X2-REG
FDA UDI
Class IActive
Regard™ GY0964
FDA UDI
Class IIUnknown
Regard™ BTNBLT-REG
FDA UDI
Class IActive
Regard™ NU0991
FDA UDI
Class IUnknown
Regard™ EY0933
FDA UDI
Class IIUnknown
Regard™ CHMG38GNSL-REG
FDA UDI
Class IActive
Regard™ OR0456
FDA UDI
Class IUnknown
Regard™ OR0058
FDA UDI
Class IUnknown
Regard™ OR0416
FDA UDI
Class IUnknown
Regard™ OR0727
FDA UDI
Class IUnknown
Regard™ EMBAG36BLU-REG
FDA UDI
Class IActive
Regard™ ET0460
FDA UDI
Class IUnknown
Regard™ GS1024
FDA UDI
Class IUnknown
Regard™ 361066REG
FDA UDI
Class IIActive
Regard™ 315717
FDA UDI
Class IIActive
Regard™ 243456
FDA UDI
Class IIActive
Regard™ A3SRGREINFSTM-REG
FDA UDI
Class IIActive
Regard™ GS0669
FDA UDI
Class IIUnknown
Regard™ T100AC-PHILIPS
FDA UDI
Class IIActive
Regard™ OR0666
FDA UDI
Class IUnknown
Regard™ 303413
FDA UDI
Class IIUnknown
Regard™ OR0354
FDA UDI
Class IUnknown
Regard™ OR1009
FDA UDI
Class IUnknown
Regard™ EY0938
FDA UDI
Class IIUnknown
Regard™ OB0100
FDA UDI
Class IIUnknown
Regard™ CV0913
FDA UDI
Class IIUnknown
Regard™ LD0846
FDA UDI
Class IIUnknown
Regard™ AN1041
FDA UDI
Class IIUnknown
Regard™ LD0693
FDA UDI
Class IIUnknown
Regard™ CV0830
FDA UDI
Class IIUnknown
Regard™ OR0993
FDA UDI
Class IUnknown
Regard™ STKIMP12X48NS-REG
FDA UDI
Class IActive
Regard™ STKCT2PL6ST-REG
FDA UDI
Class IActive
Regard™ CV0758
FDA UDI
Class IIUnknown
Regard™ GASPG2X2P12-REG
FDA UDI
Class IActive
Regard™ ABGALN1CCLL-REG
FDA UDI
Class IActive
Regard™ OR0355
FDA UDI
Class IUnknown
Regard™ GS0930
FDA UDI
Class IIUnknown
Regard™ HT0774
FDA UDI
Class IIUnknown
Regard™ A3SRGREINFSTXL
FDA UDI
Class IIActive
Regard™ GS0322
FDA UDI
Class IIUnknown
Regard™ OR0849
FDA UDI
Class IUnknown

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