Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004513970

FEI Number

3004513970

Entity Name

Resource Optimization & Innovation, LLC

City/State/Country

Nashville, TN, US

Establishment Address

1100 Dr Martin L King Jr Blvd Ste 1100, Nashville, TN 37203, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Resource Optimization & Innovation (Owner Number: 10026387)

Owner / Operator Contact Address

1100 Dr. Martin Luther King Jr. Blvd, Suite 1100, Nashville, TN 37203, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard Regard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PEZ	Central Venous Catheter Dressing Change Kit	General Hospital	Class 2	880.5200	2019-09-26
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2023-02-15
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2016-04-14
DSW	Bag, Polymeric Mesh, Pacemaker	Cardiovascular	Class 1	870.3650	2026-02-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-09-10
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-16
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-03-03
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2019-09-26
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-11-15
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2019-09-26
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-05-14
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2019-09-26
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-01-25
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2023-07-14
OFF	Central Venous Catheter Tray	Cardiovascular	Class 2	870.1140	2019-09-26
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-11-29
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-05-15
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-09-26
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2019-09-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-12-19
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2023-02-02
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2009-10-20
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2019-09-26
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2019-09-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-07-13
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-07-13
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2020-07-13
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2008-08-06
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2022-11-07
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-03-16
OHG	Circumcision Tray	Obstetrics/Gynecology	Class 2	884.4530	2008-08-06
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2023-11-29
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2019-09-26
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2019-11-06
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2022-08-23
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-11-15
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-16
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2023-04-14
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2019-09-26

Official Correspondent

Karen Wagener

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Resource Optimization & Innovation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0033-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0034-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0035-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0036-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0037-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0038-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0039-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0040-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0041-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0042-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0043-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0044-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004513970. Last updated year: 2026. Please use registration number 3004513970 when referencing this establishment in official correspondence.