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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
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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 6 of 24
DeviceModel / ReferenceRegistriesClassStatus
Regard™ STK2CTPL6NS-REG
FDA UDI
Class IActive
Regard™ GS0817
FDA UDI
Class IIUnknown
Regard™ NU0168
FDA UDI
Class IUnknown
Regard™ LD0156
FDA UDI
Class IIUnknown
Regard™ CV0966
FDA UDI
Class IIUnknown
Regard™ GY0771
FDA UDI
Class IIUnknown
Regard™ SRGHDBRDCVRTIE-REG
FDA UDI
Class IActive
Regard™ OR0762
FDA UDI
Class IUnknown
Regard™ PEDIATRIC-PHILIPS
FDA UDI
Class IIActive
Regard™ EY0266
FDA UDI
Class IIUnknown
Regard™ GS0222
FDA UDI
Class IIUnknown
Regard™ CV0482
FDA UDI
Class IIUnknown
Regard™ GS0392
FDA UDI
Class IIUnknown
Regard™ OR0180
FDA UDI
Class IUnknown
Regard™ GY0437
FDA UDI
Class IIUnknown
Regard™ OR0345
FDA UDI
Class IIUnknown
Regard™ GS0257
FDA UDI
Class IIUnknown
Regard™ CHMG53GNS2XL-REG
FDA UDI
Class IActive
Regard™ NTRLEXMS3-REG
FDA UDI
Class IActive
Regard™ DRP1-31X51ST-REG
FDA UDI
Class IIActive
Regard™ C100AC-ZOLL
FDA UDI
Class IIActive
Regard™ GY0616
FDA UDI
Class IIUnknown
Regard™ OR0148
FDA UDI
Class IUnknown
Regard™ OR0388
FDA UDI
Class IIUnknown
Regard™ BPNEO2-REG
FDA UDI
Class IIActive
Regard™ NU0974
FDA UDI
Class IUnknown
Regard™ OR0446
FDA UDI
Class IUnknown
Regard™ LD0399
FDA UDI
Class IIUnknown
Regard™ STKCTBLK1PL4NS-REG
FDA UDI
Class IActive
Regard™ CV0500
FDA UDI
Class IIUnknown
Regard™ 361067
FDA UDI
Class IIActive
Regard™ ABGKT3CC23G-REG
FDA UDI
Class IActive
Regard™ LD0843
FDA UDI
Class IIUnknown
Regard™ GY1017
FDA UDI
Class IIUnknown
Regard A2ISOG2XLNS-REG
FDA UDI
Class IActive
Regard™ HT0051
FDA UDI
Class IIUnknown
Regard™ 370003
FDA UDI
Class IIActive
Regard™ DBPADLTL-REG
FDA UDI
Class IIActive
Regard™ GS0986
FDA UDI
Class IIUnknown
Regard™ A3SRGREINFST4XL-REG
FDA UDI
Class IIActive
Regard™ NTRLEXML3-REG
FDA UDI
Class IActive
Regard™ GASPG4X4P12-REG
FDA UDI
Class IActive
Regard™ GS0797
FDA UDI
Class IIUnknown
Regard™ NU0041
FDA UDI
Class IUnknown
Regard™ GS0623
FDA UDI
Class IIUnknown
Regard™ GY0237
FDA UDI
Class IIUnknown
Regard™ OR0803
FDA UDI
Class IUnknown
Regard™ GS0082
FDA UDI
Class IUnknown
Regard™ NU0341
FDA UDI
Class IUnknown
Regard™ OR0642
FDA UDI
Class IUnknown

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